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Cell & Gene Therapy

Expert Consulting Team


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Cells Gene

Cell and Gene Therapy

At ProPharma, our Cell and Gene Therapy consulting team offers a comprehensive and integrated approach to early stage cell and gene therapy development. Our expert team provides a range of services, including IND/CTA preparation, manufacturing technology, safety and risk assessment, and development planning, to help our clients navigate the complex and ever-changing landscape of cell and gene therapy development.

By partnering with us, clients can be confident that they have access to the knowledge and expertise they need to successfully bring their therapies to market. Contact us today to learn more about how we can help you achieve success in cell and gene therapy development.

Cell and Gene Therapy Consulting & Services

Your partner for the development of advanced and novel cell and gene therapies, also known as Advanced Therapy Medicinal Products or ATMPs.

Early Stage Development

At ProPharma, we understand the emotional significance of taking your cell and gene therapy (CAGT) product from molecule to the bedside. Our unwavering commitment to your vision drives us to offer comprehensive early-stage development services that touch lives.

IND/CTA Preparation

laboratory-technician-injecting-test-tube

Turn your groundbreaking therapy into a reality with ProPharma's seasoned regulatory affairs specialists and consultants. We are your guiding light through the maze of regulatory complexities. Our experts craft meticulous and compelling Investigational New Drug (IND) applications or Clinical Trial Applications (CTAs) that capture the essence of your therapeutic potential. With our unwavering advocacy, we simplify the process and increase the likelihood of success. Let us ignite the spark of possibility and bring your vision to life.

ProPharma assists with tasks such as conducting animal/toxicology studies, developing dosing strategies, and performing long-term follow-up analyses (LTFU). Our experts also offer strategic advice and help with manufacturing and control of materials, as well as analytics and feasibility of specifications. Additionally, we help shape the design of both clinical and nonclinical studies, incorporating novel adaptive approaches.

Quality, Compliance & Manufacturing

Every step of your journey is sacred. We understand the profound responsibility of ensuring that your therapy is not only innovative but also safe and reliable. Our expert team will work hand in hand with you to establish an unwavering commitment to quality, compliance, and manufacturing excellence. Together, we will weave an unbreakable shield of protection around your therapy, ensuring that it reaches patients with the utmost integrity.

We are experts in Good Manufacturing Practices (GMP), CQV (Commissioning, Qualification, and Validation), and the development of Quality Management Systems (QMS) for inspection readiness. Our team will help you select the right contract manufacturing organizations (CMOs) and perform risk assessments of critical steps. We can help alleviate the challenges associated with analytical development, process development, validation, and mapping, as well as technology transfer.

Safety & Risk Assessment

Embrace the future with confidence, knowing that your therapy has undergone meticulous safety scrutiny. At ProPharma, we leave no stone unturned in identifying and mitigating risks. We understand the immeasurable importance of patient safety and the trust placed in your therapy. Through rigorous risk assessments and strategic planning, we will help you navigate the turbulent waters, safeguarding the dreams of those awaiting life-changing treatments.

We conduct risk-benefit evaluations and provide support in developing Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS). Our team knows how to create key clinical documents like the Investigator's Brochure (IB) and protocols. We can help address environmental risk and containment for GMO licensing and formulate safety data strategies for the Biologics License Application (BLA) or Marketing Authorization Application (MAA). And in preparation for market, our global labeling development experts will ensure you meet industry standards.

Development Planning

Every journey requires a map to guide you through uncharted territories. Together, we will chart a course, meticulously planning every milestone and overcoming hurdles along the way. Our seasoned team of experts will become your compass, providing strategic guidance and support to navigate the scientific, regulatory, and logistical challenges. Let us be your guiding star, lighting the path towards transformative success.

Our cell and gene therapy consultants and experts provide guidance in formulating an overall regulatory strategy ensures that Sponsors align their development plans with the regulatory landscape. This includes considering orphan and pediatric indications, as well as exclusivity options to maximize market exclusivity and commercial potential. Our expertise in process optimization, validation, and scalability supports Sponsors in developing robust and scalable manufacturing processes. We help define the Target Product Profile (TPP) to ensure that development efforts remain focused on meeting patient and market needs. Additionally, we’ll recommend reimbursement strategies that help Sponsors navigate the complex reimbursement landscape, enhancing the commercial potential of their future products.

technicians-collaborating-in-a-lab

Clinical Development

As your therapy transitions from the lab to real-world impact, we understand the profound emotional weight of this stage. At ProPharma, we stand shoulder to shoulder with you, providing unwavering support and empowering you to make a lasting difference.

Clinical Trial Execution and Support

Every trial holds the potential to change the course of history. With our deep understanding of the unique nature of each trial, we tailor our comprehensive clinical trial services to meet your specific needs and objectives. Our experienced team guides you through the intricacies of clinical research, ensuring the safe and efficient delivery of your innovative therapies to patients. From protocol design to patient recruitment, data management to analysis, we leave no stone unturned in upholding the highest standards of scientific rigor. Together, we will create a chapter of hope, courage, and resilience, making a lasting impact.

ProPharma’s cell and gene therapy consultants provide comprehensive clinical trial support that addresses the unique challenges and complexities of these groundbreaking therapies. Our full-service clinical trials cover every aspect of the trial process, including protocol design, patient recruitment, and data management. With adherence to the highest scientific standards, our experienced team offers specialized expertise in patient eligibility, treatment administration, and follow-up assessments.

Additionally, we offer functional service provider solutions, allowing you to leverage our expertise in specific areas such as medical writing, biostatistics, and clinical monitoring. We embrace decentralized clinical trials, bringing the trial directly to the patient's home or local healthcare setting through remote capabilities and innovative technologies. Our embedded solutions further enhance support and integration by seamlessly becoming an extension of your team, optimizing trial design, execution, and project management.

Partner with ProPharma to navigate the complexities of cell and gene therapy clinical trials and unlock the full potential of your groundbreaking therapies. Together, we will make a meaningful difference in the lives of patients and contribute to the advancement of medical science.

CMC & Manufacturing for CAGT

Witness the culmination of your efforts as your therapy takes shape within the walls of our trusted manufacturing partners. We leave no room for compromise when it comes to Chemistry, Manufacturing, and Controls (CMC). With meticulous precision, we will optimize your manufacturing processes, ensuring that each dose carries the essence of your vision. Together, we will breathe life into your therapy, igniting the flames of hope.

At ProPharma, we offer comprehensive CMC & Manufacturing services for cell and gene therapy products. Our expertise spans across various key areas, ensuring the highest standards of quality, compliance, and efficiency throughout the manufacturing process. We work closely with you to develop a global CMC strategy, encompassing all necessary regulatory requirements and considerations. With a focus on Quality by Design (QbD) and Quality Risk Management, we meticulously analyze and optimize your manufacturing processes, mitigating risks and maximizing product quality. Our team includes Qualified Persons (QP) and Responsible Persons (RP) for EU release and distribution, providing the necessary expertise to navigate the regulatory landscape and ensure compliance. Additionally, we conduct supply chain audits to ensure the integrity and reliability of your therapy's supply chain. With our end-to-end CMC and manufacturing capabilities, we empower you to bring your cell and gene therapy products to patients with confidence and integrity.

Regulatory Strategy and Submissions

Clear the path for your therapy to reach those in need. Our experienced regulatory affairs team will stand by your side, crafting a strategic roadmap for regulatory success. We will immerse ourselves in the intricate dance of regulations, leveraging our expertise to navigate the ever-evolving landscape. Let us shoulder the burden of regulatory complexities, allowing you to focus on what truly matters: transforming lives.

ProPharma's Regulatory services encompass a comprehensive range of expertise to support the successful development and approval of cell and gene therapy products. Our regulatory experts specialize in developing robust regulatory strategies for both the US and EU markets, ensuring compliance with regional requirements. We also assist in planning evidence strategies for reimbursement, helping you navigate the complex landscape of healthcare reimbursement systems.

Our close collaboration with regulatory agencies includes providing advice and conducting pre-submission meetings to address any potential concerns or queries. We have extensive experience in the development and implementation of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS), as well as the preparation of Product Safety Management Files (PSMF). Our skilled medical writers contribute to the development of high-quality regulatory documents, including the authoring and publishing of clinical and scientific manuscripts.

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Finally, we offer expert support in the submission and management of Biologics License Applications (BLA) for the US market and Marketing Authorization Applications (MAA) for the EU market. Partner with us to navigate the complex regulatory landscape, ensuring compliance and maximizing the potential for successful approval of your cell and gene therapy products.

Speak with an Expert

Commercialization

The moment has come to bring your therapy to the world, and we understand the profound emotions that accompany this pivotal stage. At ProPharma, we will be your guiding light, helping you navigate the path to successful commercialization:

Product Launch

A symphony of excitement and anticipation fills the air as your therapy prepares to make its grand entrance into the world. Our commercialization experts will orchestrate a flawless launch, meticulously planning every detail to maximize impact and reach. We understand the transformative power of first impressions, and together, we will captivate the world with your therapy's potential.

ProPharma offers comprehensive support for product launches, ensuring a successful introduction of your cell and gene therapy products to the market. Our services encompass various crucial aspects, including process validation and continued process verification to ensure the reliability and consistency of manufacturing processes. We also provide guidance on Good Distribution Practice Quality Management Systems (GDP QMS) to ensure the integrity and safety of your products throughout the supply chain. Additionally, we assist in the implementation of compassionate use programs and post-authorization safety studies (PASS) to address the needs of patients and collect real-world evidence. Our consulting expertise extends to product lifecycle management, encompassing strategies to optimize product performance and adapt to evolving market dynamics. We also provide guidance on reimbursement strategies, helping you navigate the complex landscape of healthcare reimbursement systems to maximize access to your therapy. Our regulatory intelligence services keep you up to date with the latest regulatory requirements and trends. Lastly, we offer review services for promotional materials, ensuring compliance with regulatory guidelines in both the EU and US markets. With our comprehensive support, you can confidently navigate the product launch phase, ensuring a successful market entry for your cell and gene therapy products.

Global Patient Safety

The safety of patients is our unwavering priority. As your therapy spreads its wings across borders, we will ensure a harmonized global patient safety strategy. Our vigilant pharmacovigilance experts will establish robust systems to monitor and address any safety concerns swiftly and comprehensively. Trust us to safeguard the well-being of patients around the globe, allowing your therapy to shine as a beacon of hope.

ProPharma prioritizes global patient safety, offering comprehensive services to ensure the well-being of patients receiving cell and gene therapy products. Our expertise includes the establishment of Global Vigilance and Pharmacovigilance Quality Management Systems (GVP QMS) to ensure robust safety monitoring and reporting processes. We provide Medical Information (MI) inquiries support, offering 24/7/365 MI contact center services in over 30 native languages to address queries from healthcare professionals and patients. Our dedicated team handles the intake, processing, and aggregate reporting of adverse events and serious adverse events (AE/SAE) to regulatory authorities. We also have qualified personnel, including the EU Qualified Person for Pharmacovigilance (QPPV) and Local Persons for Pharmacovigilance (LPPV), who oversee the compliance of pharmacovigilance activities. Additionally, we utilize EudraVigilance, the European database for the collection and analysis of suspected adverse reactions, to enhance safety surveillance and reporting. With our comprehensive global patient safety services, you can be confident in the integrity and vigilance of your cell and gene therapy products, ensuring the utmost safety for patients worldwide.

Program Types

ProPharma provides comprehensive support for a wide range of cell and gene therapy programs, enabling the development and advancement of transformative treatments.

Our consulting and expertise extends to various program types, including:

  • CAR-T cells (autologous and allogenic)
  • TILs (Tumor-infiltrating lymphocytes)
  • AAVs, dual AAVs
  • Gene-editing
  • Vector-based gene transfer
  • Stem cells, MSC and iPSCs
  • Therapeutic vaccines
  • Tissue engineering products
  • Combination products
  • γδ T cells
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Therapeutic Areas

Our team of cell and gene therapy consultants and experts possesses extensive experience across a diverse range of therapeutic areas, allowing us to provide specialized support tailored to your specific indications. We have a deep understanding of the unique requirements and complexities associated with different therapeutic areas. Whether your focus lies in oncology, hemato-oncology, or tissue-agnostic indications, we have the knowledge and expertise to support your program. Our therapeutic expertise includes:

  • Oncology, hemato-oncology, tissue-agnostic indications
  • Hematology: hemophilia B, hemophilia A, thalassemia, sickle cell disease, porphyria
  • Inherited retinal disorders (IRDs)
  • Autoimmune diseases
  • Other rare diseases: paroxysmal nocturnal hemoglobinuria (PNH), phenylketonuria (PKU), GM2 gangliosidosis, Kra

Speak with an Expert

Decentralizing the Manufacturing of Cell and Gene Therapy Products

Decentralizing the manufacturing of cell and gene therapy products is a transformative approach that brings production processes closer to the point of care or the patient population. Shifting away from a centralized manufacturing model aims to overcome challenges associated with personalized and patient-specific therapies. By localizing manufacturing, logistical hurdles, transportation issues, and time constraints can be minimized, ensuring patients receive timely access to life-changing treatments.

This decentralized approach offers numerous benefits, including enhanced accessibility, streamlined supply chains, and increased flexibility. Patients can receive therapies more efficiently, as manufacturing can be tailored to individual needs and administered promptly. However, decentralization also presents challenges such as maintaining consistent quality control, regulatory compliance, and establishing robust infrastructure at multiple locations.

technician-observing-test-tube-writing-in-notebook

At ProPharma, we embrace the significance of decentralizing cell and gene therapy manufacturing. With our expertise and industry insights, we help clients navigate the complexities of this emerging trend. Through strategic guidance, regulatory support, and operational excellence, we optimize manufacturing processes and unlock the full potential of decentralized models.

Together, we shape a future where innovative treatments are readily accessible, overcoming the limitations of centralized manufacturing and bringing hope to patients in need.

Read our Cell and Gene Therapy Decentralized Manufacturing White Paper

Download the White Paper

Our Approach

ProPharma partners with clients to provide comprehensive expertise and tailored solutions across all stages of cell and gene therapy product development, ultimately helping clients to navigate the complex regulatory landscape, manage risks, ensure product quality and safety, and successfully bring their products to market, thereby making a meaningful impact on patients' lives.

Deep Domain Expertise Across the Full Product Lifecycle Support

Custom Solutions for Complex CAGT Needs

Reimbursement Strategies & Financial Plan Development

Bridging Science & Regulatory Strategy

We understand the uniqueness associated with CAGT products and are here to bridge the gap between scientific development and the regulatory framework. Our experts facilitate discussions with regulatory agencies to agree on the optimal nonclinical, CMC, and clinical development.

Your "Product is the Process"

Our consultants and experts will guide you through taking your CAGT product from the lab, through tech transfer, to clinical and regulatory approval.

We know what challenges to watch out for and can help you through each milestone, taking the product from the lab to a GMP facility and clinical/commercial scale.

Multi-Disciplinary Team with Global Expertise

Our global team of subject matter experts bring decades of experience with authorities around the world.

We have the knowledge of quality assurance and ensuring GxP in development in combination with scientific, technical, and leading cell & gene regulatory experience.

Speed to Scale

We can quickly scale and fully train individuals for a single task or teams of 1,000+ for short-term needs or long-term goals locally or globally.

Supporting Digital Transformation

Our digital data and technology experts transform data into learning allowing scientists to identify key indicators faster and solutions sooner for your CAGT product.

Experience with Formularies, Insurance, and Providers

ProPharma excels in navigating the intricacies of reimbursement, coverage, and access for cell and gene therapy products, ensuring optimal market penetration and patient affordability.

Reimbursement

ProPharma's expert cell and gene consulting team has the capabilities to support market access within Europe and the United States and assure success in reimbursement strategies.

Moreover, our team is a unique partner to support early engagement with Health Technology Assessment (HTA) bodies, since our clinical regulatory experts and market access specialists closely collaborate to help you streamline the development and launch of new therapies.

Financial Plan Development

We help clients create a financial plan that they can bring to investors to show when funding is required, how much funding is needed, and what the benefit of the funding is. We can provide guidance for when to invest in infrastructure versus investing in analytics, or other key packages.

Our cell and gene therapy consulting team works with you to ensure funding requirements are understood, utilized efficiently, and results-oriented.

Deep Domain Expertise Across the Full Product Lifecycle Support

Click here to expand this section

Bridging Science & Regulatory Strategy

We understand the uniqueness associated with CAGT products and are here to bridge the gap between scientific development and the regulatory framework. Our experts facilitate discussions with regulatory agencies to agree on the optimal nonclinical, CMC, and clinical development.

Your "Product is the Process"

Our consultants and experts will guide you through taking your CAGT product from the lab, through tech transfer, to clinical and regulatory approval.

We know what challenges to watch out for and can help you through each milestone, taking the product from the lab to a GMP facility and clinical/commercial scale.

Custom Solutions for Complex CAGT Needs

Click here to expand this section

Multi-Disciplinary Team with Global Expertise

Our global team of subject matter experts bring decades of experience with authorities around the world.

We have the knowledge of quality assurance and ensuring GxP in development in combination with scientific, technical, and leading cell & gene regulatory experience.

Speed to Scale

We can quickly scale and fully train individuals for a single task or teams of 1,000+ for short-term needs or long-term goals locally or globally.

Supporting Digital Transformation

Our digital data and technology experts transform data into learning allowing scientists to identify key indicators faster and solutions sooner for your CAGT product.

Reimbursement Strategies & Financial Plan Development

Click here to expand this section

Experience with Formularies, Insurance, and Providers

ProPharma excels in navigating the intricacies of reimbursement, coverage, and access for cell and gene therapy products, ensuring optimal market penetration and patient affordability.

Reimbursement

ProPharma's expert cell and gene consulting team has the capabilities to support market access within Europe and the United States and assure success in reimbursement strategies.

Moreover, our team is a unique partner to support early engagement with Health Technology Assessment (HTA) bodies, since our clinical regulatory experts and market access specialists closely collaborate to help you streamline the development and launch of new therapies.

Financial Plan Development

We help clients create a financial plan that they can bring to investors to show when funding is required, how much funding is needed, and what the benefit of the funding is. We can provide guidance for when to invest in infrastructure versus investing in analytics, or other key packages.

Our cell and gene therapy consulting team works with you to ensure funding requirements are understood, utilized efficiently, and results-oriented.

Cell & Gene Therapy Consultants & Experts

Robert Beall

Robert Beall, PMP

Vice President Cell and Gene Therapy Center of Excellence

Paula van Hennik

Paula van Hennik

Group Head Medical and Regulatory Sciences

Anne Flament

Anne Flament

Medical Director Clinical Research Solutions

Simona Guidi

Simona Guidi

Senior Consultant

Marshall Scicchitano

Marshall Scicchitano

Vice President Nonclinical/Emerging Therapies

Eleonora Casucci

Eleonora Casucci

Vice President Quality and Compliance EU/UK/India and CEO of ProPharma MIA License B.V.

Laura Fiammenghi

Laura Fiammenghi

Qualified Person and Senior Consultant

Dave Bezick

Dave Bezick

Director Medical Information

Eliot Randle

Dr. Eliot Randle MBA

SVP Digital Transformation

Erik Schagen

Erik Schagen

Director Regulatory Sciences

Jens van Wijngaarden

Dr. Jens van Wijngaarden

Senior Director Regulatory Sciences

Elizabeth Soames

Elizabeth Soames

Group Head Non-Clinical Regulatory Sciences

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Innovation is Our Foundation

Our industry is in constant flux. If you don’t evolve, you’ll be left behind. Our teams combine agility with deep expertise to innovate across the full development pipeline. We’ve invented a process that suits today’s needs.

5 Challenges in the Development of Cell and Gene Therapies

The development of cell and gene therapies is a slow, risky, and expensive business. 

Download our guide that covers how to avoid common pitfalls that can derail CAGT products before they reach the market.

Download: 5 Challenges in the Development of Cell & Gene Therapy

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Case Study Ensure Data Integrity Compliance to Prevent Audit Findings - ProPharma

September 28, 2023

Ensure Data Integrity Compliance to Prevent Audit Findings

Ensuring accurate and honest data collection is essential for maintaining the integrity of research. Even though the right mindset is the start of data integrity compliance, that alone is not enough...

Videos Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

September 1, 2022

Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...

Videos Insider Talks - Tips From Qualified Persons for Successful Importation - ProPharma

June 27, 2022

Insider Talks - Tips From Qualified Persons for Successful Importation

Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets? You are in the process of obtaining an MA or CTA to bring your product to EEA/UK markets, which can be a complex...

Case Study Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence - ProPharma

October 14, 2021

Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence

Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

Case Study Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons - ProPharma

October 14, 2021

Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons

Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

Case Study EU Medical Device Regulation PMO and Project Delivery  - ProPharma

October 14, 2021

EU Medical Device Regulation PMO and Project Delivery

Regardless of your internal resources, it could be extremely taxing and unrealistic to expect your team to accomplish both their normal daily activities as well as the work necessary to ensure...

Case Study Growing a Culture of Quality and Compliance - ProPharma

November 2, 2021

Growing a Culture of Quality and Compliance

One of the main challenges in adopting a global enterprise quality management system is the complex nature of separate existing tools, applications, and spreadsheets that companies often acquire or...

Case Study How a Two-Part NDA Regulatory Strategy Resulted in Submission Success - ProPharma

September 28, 2023

How a Two-Part NDA Regulatory Strategy Resulted in Submission Success

Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...

Case Study How to Ensure Your Multi-Million Dollar Software Launches on Time - ProPharma

October 14, 2021

How to Ensure Your Multi-Million Dollar Software Launches on Time

Launching a large, enterprise technology solution with a global team is a big undertaking for even the most experienced teams and largest companies. Implementing a technology solution of this...

Case Study How to Manage a Drug Product in a Medical Device Environment - ProPharma

June 1, 2022

How to Manage a Drug Product in a Medical Device Environment

A global medical device company asked ProPharma to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined how it...

Case Study How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach - ProPharma

October 4, 2021

How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach

A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

Case Study How to Successfully Launch Products with QMS and QP Certification - ProPharma

October 14, 2021

How to Successfully Launch Products with QMS and QP Certification

Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a...

Case Study Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline - ProPharma

October 14, 2021

Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline

Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...

Case Study Increased Visibility for Senior Management with Custom PMO Design, Implementation - ProPharma

October 4, 2021

Increased Visibility for Senior Management with Custom PMO Design, Implementation

Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...

Case Study Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days - ProPharma

October 14, 2021

Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days

In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...

Case Study Laboratory Informatics with Robotics - ProPharma

October 4, 2021

Laboratory Informatics with Robotics

Workflows between Electronic Lab Notebooks (ELNs), Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), instruments, and robotics are immensely complex and...

Case Study Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance - ProPharma

October 14, 2021

Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance

When performing initial qualification audits, it’s important to evaluate all critical systems evenly to ensure compliance. Lack of evaluation of all critical systems can leave Sponsors and their...

Case Study Managing Complex Pharmaceutical Projects - ProPharma

October 4, 2021

Managing Complex Pharmaceutical Projects

There are many obstacles your team may face during product development. One of the hurdles includes project management struggles associated with having too many decision makers. Although it is one...

Case Study MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction - ProPharma

October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...

Case Study Navigating QMS Requirements from a Medical Device Perspective - ProPharma

April 12, 2022

Navigating QMS Requirements from a Medical Device Perspective

Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...

Videos Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life - ProPharma

September 28, 2023

Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life

In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...

Case Study Overworked Medical Device Teams Missing Deadlines - ProPharma

October 14, 2021

Overworked Medical Device Teams Missing Deadlines

Is your company experiencing rapid growth? Is your team overworked and falling further and further behind? ProPharma Group’s team can help. You may recognize that this is happening but not...

Videos Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective - ProPharma

May 19, 2022

Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective

As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...

Case Study Program and Project Management Effectively Deliver a QMS Optimization Program - ProPharma

April 25, 2022

Program and Project Management Effectively Deliver a QMS Optimization Program

Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very little time for addressing prioritized...

Videos Insider Talks - To Decentralize or Not to Decentralize … That is the Question - ProPharma

March 25, 2022

Insider Talks - To Decentralize or Not to Decentralize … That is the Question

Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

Case Study Reduced Burden for Oncology Patients With Decentralized Visits - ProPharma

March 21, 2022

Reduced Burden for Oncology Patients With Decentralized Visits

Learn how our team helped implement decentralized visits for an oncology study that reduced patient burden and stress on the sites. Oncology studies often require frequent sample collection visits....

Videos AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

February 4, 2022

AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!

Case Study Secure Timely Product Launch by Ensuring GDP Compliance Across Europe - ProPharma

October 14, 2021

Secure Timely Product Launch by Ensuring GDP Compliance Across Europe

Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

Case Study Sponsor Successfully Completes Acquisition After Efficient PMA Submission - ProPharma

July 26, 2022

Sponsor Successfully Completes Acquisition After Efficient PMA Submission

A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how...

Case Study Statistical Analytics with Machine Learning Tool Enablement - ProPharma

October 14, 2021

Statistical Analytics with Machine Learning Tool Enablement

Introducing new tools is difficult and comes with a learning curve for even the most experienced, and having clearly defined processes and procedures is critical to your team’s success. If there is...

Videos 20 Years of Improving Patient Health and Safety - ProPharma

January 25, 2022

20 Years of Improving Patient Health and Safety

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Case Study Supporting Decentralized Gene Therapy Visits - ProPharma

February 17, 2022

Supporting Decentralized Gene Therapy Visits

Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study....

Videos Cohort Management Process and Planning: Challenges, Risks, and Mitigations - ProPharma

December 7, 2021

Cohort Management Process and Planning: Challenges, Risks, and Mitigations

Learn novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.

Videos Expedited Programs Explained: How to Expedite Product Approval in the US and Europe - ProPharma

November 12, 2021

Expedited Programs Explained: How to Expedite Product Approval in the US and Europe

Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!

Case Study Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors - ProPharma

October 14, 2021

Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors

Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

Videos What Does it Take to Build a Legacy? (20th Anniversary Video) - ProPharma

October 15, 2021

What Does it Take to Build a Legacy? (20th Anniversary Video)

Case Study Understanding Clinical Trial Requirements for Medical Device Label Extensions - ProPharma

October 14, 2021

Understanding Clinical Trial Requirements for Medical Device Label Extensions

After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

Case Study Using Science to Achieve EMA Approval for a First-in-Class Indication - ProPharma

October 14, 2021

Using Science to Achieve EMA Approval for a First-in-Class Indication

See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...

Videos The True Cost of Non-Compliance - ProPharma

October 13, 2021

The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.

Case Study When a Team Lacks Industry Experience - ProPharma

October 14, 2021

When a Team Lacks Industry Experience

Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

October 14, 2021

When a Team Loses Their Leader and Lacks a Plan

Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...

Videos ProPharma Group Overview Video  - ProPharma

October 4, 2021

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Guide Assess Your Readiness for Supplying Drug Product to Europe and UK

June 16, 2023

Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC

Assessing your progress is of utmost importance when supplying pharmaceutical products to the European Union (EU), United Kingdom (UK), and European Economic Community (EEC), as it ensures compliance...

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

September 28, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers EU IVDR Progress Self Assessment - ProPharma

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

September 28, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Group Services Overview - ProPharma

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

September 28, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients

October 17, 2021

Outsourcing of Medical Information Content Creation: Experience of 100 Clients

The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

Whitepapers Good Science Presented Well Generates Approval

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook Evolving EMEA MI Service Models

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers What You Need to Know About GxP Independent Compliance Audits

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource

October 4, 2021

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

eBook Improving Product Quality During Technical Transfers

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

March 31, 2023

6 Key Elements of Successful Drug & Device Development in Europe

Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...

Case Study CMC Program Management Case Study

March 24, 2023

CMC Program Management

Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...

Case Study Drug Development Program Management Case Study

March 24, 2023

Drug Development Program Management

Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...

Case Study Medical Affairs Case Study

March 24, 2023

Medical Affairs

Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...

Case Study Medical Safety Scientist Case Study

March 24, 2023

Medical Safety Scientist

This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...

Case Study Quality and Analytical Scientist Case Study

March 24, 2023

Quality and Analytical Scientist

Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...

Case Study Regulatory Affairs Project Manager Case Study

March 24, 2023

Regulatory Affairs Project Manager

The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...

Case Study SOPs and Processing Mapping Case Study

March 24, 2023

SOPs and Processing Mapping

This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

March 29, 2023

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

Guide 6 Things to Consider When Selecting a Research Platform

April 6, 2023

6 Things to Consider When Selecting a Research Platform

Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

May 3, 2023

Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...

Guide Maximizing Patient Outcomes. A Contact Center Needs Assessment.

May 16, 2023

Maximizing Patient Outcomes. A Contact Center Needs Assessment.

Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

May 24, 2023

5 Key Challenges in the Development of Cell & Gene Therapy

Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...

Case Study FSP models for IVD Clinical Trials:  Meeting Growing Pipeline Demands

June 12, 2023

FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands

Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...

Flyers Functional Service Provider (FSP) Value Proposition

June 21, 2023

Functional Service Provider (FSP) Value Proposition

At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...

Flyers Labeling Development & Intelligence

June 21, 2023

Labeling Development & Intelligence

Our cutting-edge labeling intelligence solution at ProPharma empowers our highly skilled labeling development consultants to offer an unmatched product development strategy and top-tier labeling...

Case Study Enhancing Site Capacity for Clinical Trials with DCT Nurses

June 27, 2023

Enhancing Site Capacity for Clinical Trials with DCT Nurses

Discover how ProPharma helped a US biotech company focused on rare neurologic conditions overcome challenges in securing qualified resources for their study sites. Our FSP solutions, featuring study...

Whitepapers Compliance Auditing: Diving into Common Critical Findings

July 31, 2023

Compliance Auditing: Diving into Common Critical Findings

Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...

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