health authority review

Building regulatory roadmaps to ease your way through development.  

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Regulatory compliance solutions 

Our aim is to help your business succeed by working to streamline the pharma regulatory process. ProPharma’s experienced regulatory consulting and FDA compliance team commands an unparalleled breadth and depth of knowledge pertaining to the FDA and EMA regulatory frameworks and can work with you to accomplish your business objectives.

Our regulatory consultants develop detailed strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We can also help with your post-authorization regulatory pharma needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.

Health Authority Review

Our veteran regulatory sciences team has over 30 years of experience using scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes with regulatory agencies in the US and Europe. Explore all the ways that ProPharma can support your pharmaceutical regulatory affairs needs and product pipeline throughout the entire product lifecycle or speak with one of our regulatory consulting experts.

Life Cycle Management

A comprehensive scientific and regulatory strategy across all stages of the product lifecycle can help your team define a plan for long-term growth and success. After approval of your initial marketing authorization application (MAA), you need to remain compliant with all regulatory requirements (eg, post-authorization commitments, variations, renewals) to keep the product on the market. A strategic approach to lifecycle management is also valuable to maximize the potential of the product, potentially through line extensions or additional indications.

Acting as an extension of your team, ProPharma’s expert regulatory consultants bring a deep understanding of effective lifecycle management and have the knowledge to offer a complete regulatory solution for your product when marketed in the European Union (EU)/European Economic Area (EEA). We can partner with your team to provide:

  • Regulatory advice
  • Health authority liaison services
  • Variation applications, line extensions, and renewals
  • Support for post-authorization commitments
  • Product information (PI) updates/translations
  • Artwork reviews
  • Management of catalog texts and local regulatory databases
  • Readability testing

Talk with an Expert

Line Extensions (LE) and Variations

Acquiring marketing authorization for a new medicinal product is an achievement in its own right but is often only the first of many benchmarks in the life of the product. Line extensions (LE) made possible through new indications, added formulations, and expanded drug delivery mechanisms are some of the ways an initial product can evolve to extend patent exclusivity and reach new markets, while helping to improve the health and safety of more patients. Looking ahead at LE opportunities while maintaining consistency in the quality and manufacturing processes of an in-market product is a complex challenge faced by many marketing authorization holders (MAHs).

Woman looking into a microscope

Whether you are preparing for an LE or evaluating a potential variation to your product’s chemistry, manufacturing, and controls (CMC) process, ProPharma can help you successfully navigate the clinical, operational, and documentation aspects of the variation. We can work as an extension of your team or take care of the entire package, partnering with you to help maintain compliance throughout every change by:

  • Developing a regulatory strategy for extending your product line or lifecycle
  • Advising on regulatory requirements for variations and acting as project manager for the process
  • Compiling, writing, preparing, and publishing the submission
  • Serving as the primary point of contact with national and local health authorities

License Renewal

Throughout the product’s lifecycle, MAHs have an obligation to ensure the PI reflects current scientific data, the product safety information remains up to date, and the benefit-risk balance is still positive. Health authorities have strict legislative procedures for license renewal assessments and often require additional data or documentation, which may create challenges for your company. Having the appropriate resources to act quickly and efficiently is critical, as any misstep could have negative implications for your product’s license.

At ProPharma, our experts have a deep understanding of the science behind your product and are equally knowledgeable about the regulatory process and the expectations of the regulators. As an extension of your team, we can help you with every aspect of the license renewal process by:

  • Managing timelines and documentation throughout the process, including submissions
  • Preparing and submitting the renewal package
  • Managing responses and communication with the European Medicines Agency (EMA) or local authorizing agencies as they arise

License Renewal

Product Information

To ensure regulatory compliance, product information — including the summary of product characteristics, labeling, and package leaflet — must apply strict criteria and follow guidelines mandated by relevant filing procedures (ie, centralized, decentralized, national, or mutual recognition). Product information (PI) documents need to be accurate in multiple languages, requiring applicants to have a thorough understanding of local and national processes and the ability to translate documentation, standard statements, and terms to various European languages, including Icelandic and Norwegian.

At ProPharma, we understand the science behind your product and have a deep understanding of PI expectations from the EMA and national authorities. Throughout the application and post-authorization processes, our experts provide a wide range of PI services, including:

Core Data Sheet including safety information and materials relating to indications, dosing, and pharmacology. Our experts help develop the Core Data Sheet, and make sure all regulatory requirements and timelines are met
  • Local labels/harmonization text to harmonize national provisions so labeling is consistent throughout the EU marketplace.
  • We understand the specific requirements of local health authorities and can assist with preparing and submitting all supporting documents
  • Translations from English to various national languages within the EU. We help manage translations and assist in handling linguistic reviews to ensure accuracy for packaging, labeling, package leaflets, and artwork
  • Implementation of PI changes to ensure all changes, including new adverse events or expanded indications, are up to date and compliant with all applicable regulations and requirements. We prepare and submit all supporting documents and can assist with ongoing maintenance and updates of PI changes based on EU and local regulatory requirements

 

Patient Testing

 

Patient Information Leaflet (PIL) Testing

Patient Information Leaflet (PIL) readability testing is a legislative requirement for all medicines in Europe.

All medicines are required by European and UK law to be accompanied by a PIL setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use their medicine safely and appropriately.

ProPharma offers a comprehensive PIL readability solution from new studies to bridging reports.

Health Authority Interaction

health-authority-interaction

 

At ProPharma, our regulatory experts are scientists with a deep understanding of the intricacies of regulatory operations. Our veteran regulatory sciences team has over 30 years of experience using scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes with regulatory agencies in the US and Europe. 

Explore all the ways that ProPharma can support your pharmaceutical regulatory affairs needs and product pipeline throughout the entire product lifecycle or speak with one of our regulatory consulting experts.

Explore Our Services

Regulatory Strategy

As the global leader in regulatory consulting, ProPharma is able to develop a complete strategy that will give you confidence in the forecast of key milestones, necessary documentation, overall effort, cost, and plan of action. A sound strategy is a crucial component to success, as it provides input into all drug development efforts.

Regulatory Strategy Consulting Experts

ProPharma will work with you to develop an appropriate and effective strategy to get your product to market. Our team of experts will combine knowledge of your product with years of experience (including pre-clinical, clinical, chemistry, manufacturing, and controls (CMC), drug safety, and pharmacokinetics) and literature research on your product and similar approvals. The final regulatory strategy for your product will balance risk, speed to approval, and cost to provide you with a description of the most appropriate regulatory path and explain why this path is the rational choice.

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Global Quality & Compliance

ProPharma specializes in solving complex challenges.  Our experienced consulting professionals will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and will work side-by-side with you to implement improvement plans and collaborate with your team in addressing those risks.

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From early concept development through each clinical phase, product launch, and commercialization, our Quality and Compliance Consultants partner with clients around the world to help ensure regulatory expectations are met, business goals are achieved, and patient health and safety is assured and improved.  We do this with an unwavering focus on delivering the highest quality services through our diverse team of qualified subject matter experts. Having working experiences from large international corporations to small research companies as well as authorities such as FDA, EMA, MHRA, and national competent authorities, our experts drive operational excellence, and provide a sincere commitment to providing high-quality services. Our ability to be nimble coupled with a passion for excellence ensures our consulting services exceed clients’ expectations.

ProPharma performs quality and compliance consulting activities in all GxP areas.  Our consultants have extensive management and operational experience in at least one GxP area (GMP, GDP, GVP, GCP, GLP, GCLP, and/or IT/CSV) and often in multiple areas of expertise.

Explore Quality & Compliance

News & Insights

Life Science Consulting

December 6, 2022

Changes to the Animal Welfare Act Affecting Animal Research Facilities

Does your organization conduct or outsource testing to an Animal Research Facility?  If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...

Regulatory Sciences

November 2, 2022

Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...

Life Science Consulting

November 1, 2022

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...

Acquisitions

February 6, 2023

ProPharma buys DLC in latest services-focused takeover

On January 31st, 2023, Clinical Insider, a weekly clinical trials newsletter, published a blog post mentioning ProPharma's recent acquisition of Digital Lab Consulting (DLC) and ProPharma's release...

Company News Acquisitions

January 25, 2023

ProPharma Announces Acquisition of Digital Lab Consulting

PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING  TO EXPAND R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25, 2023: ProPharma Group (ProPharma) the...

Press Releases News

January 9, 2023

ProPharma Group launches revolutionary new operating model

$50m investment and rebrand unveiled at J.P. Morgan Healthcare Conference as part of new global growth strategy. RALEIGH, NC, January 9, 2023: ProPharma Group – the end-to-end, global provider of...

May 3, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

December 21, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Infographic Infographic

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Webinar Webinar

September 27, 2022

Free Webinar: Effective FDA Engagement

FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...

Infographic Infographic

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...

News & Insights

Acquisitions

February 06, 2023

ProPharma buys DLC in latest services-focused takeover

On January 31st, 2023, Clinical Insider, a weekly clinical trials newsletter, published a blog post mentioning ProPharma's recent acquisition of Digital Lab Consulting (DLC) and ProPharma's release...

Company News Acquisitions

January 25, 2023

ProPharma Announces Acquisition of Digital Lab Consulting

PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING  TO EXPAND R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25, 2023: ProPharma Group (ProPharma) the...

Press Releases News

January 09, 2023

ProPharma Group launches revolutionary new operating model

$50m investment and rebrand unveiled at J.P. Morgan Healthcare Conference as part of new global growth strategy. RALEIGH, NC, January 9, 2023: ProPharma Group – the end-to-end, global provider of...

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May 03, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

December 20, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Life Science Consulting

Dec 6, 2022 12:00:00 AM

Changes to the Animal Welfare Act Affecting Animal Research Facilities

Does your organization conduct or outsource testing to an Animal Research Facility?  If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...

Regulatory Sciences

Nov 2, 2022 12:00:00 AM

Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...

Life Science Consulting

Nov 1, 2022 12:00:00 AM

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...

Infographic

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Webinar

September 27, 2022

Free Webinar: Effective FDA Engagement

FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...

Infographic

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...

Infographic

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Infographic

February 7, 2023

Pathways to Market for Medical Devices in the U.S.

Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...

Case Study

October 14, 2021

Accelerate European Market Access with Compliant and Comprehensive MAA Submission

Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

Case Study

February 3, 2022

An Inspection-Ready QMS Accelerates Product Introductions in Europe

Accessing new market is in the European Union can be a challenge especially when having to navigate both specific country and general European regulation. Read how ProPharma Group used their deep...

Case Study

November 30, 2021

Bespoke Regulatory Sciences Teams for Pharmaceutical Companies

Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team. ProPharma Group’s team of Regulatory Sciences...

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March 18, 2022

Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements

There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...

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October 4, 2021

Clinical Monitoring Change Management

Translating regulatory guidance into success for your organization is difficult when there is not a consistent industry standard. Coupled with new processes and procedures within a company that has a...

Case Study

March 22, 2022

Decentralized Visits in Rare Disease Studies

Learn how ProPharma Group helped implement and execute decentralized visits for a pediatric rare disease study. The COVID-19 pandemic caused major disruption to many clinical trials and the...

Case Study

October 14, 2021

Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area

Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...

Case Study

February 7, 2023

Early Phase Oncology Program in Patients with Solid Tumors

See how we helped an emerging Biotech Sponsor achieve an enrollment rate and average time to FPI that is well above industry benchmarks. An emerging Biotech Sponsor needed management and full-service...

Case Study

November 12, 2021

EMA Approval Under Exceptional Circumstances

How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval. You’ve developed a novel drug and obtained FDA approval. Your work is done, right? Not if...

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February 7, 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

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

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

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...

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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...

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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...

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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...

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February 7, 2023

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

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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...

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June 1, 2022

How to Manage a Drug Product in a Medical Device Environment

A global medical device company asked ProPharma Group 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...

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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...

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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...

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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...

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October 4, 2021

Increased Visibility for Senior Management with Custom PMO Design, Implementation

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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...

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October 4, 2021

Laboratory Informatics with Robotics

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October 14, 2021

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

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October 4, 2021

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October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

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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...

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February 7, 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...

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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

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

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...

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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

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

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

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...

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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...

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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

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.  

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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

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

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

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...

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October 15, 2021

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

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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...

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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

October 13, 2021

The True Cost of Non-Compliance

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

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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...

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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

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.  

Flyers

August 8, 2022

QP MIA Survey - Progress Self-Assessment

Use this readiness questionnaire to assess the current state of your progress.

Whitepapers

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

February 7, 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

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.

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October 14, 2021

EMA Services: Ensure Regulatory Success

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

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February 7, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

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October 14, 2021

Cell and Gene Therapy Center of Excellence

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

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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

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October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

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October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

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October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

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October 4, 2021

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

Reduce Launch Timeline and Improve Business Efficiency

Flyers

February 7, 2023

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

Save Time and Boost your Bottom Line

eBook

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

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

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

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

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

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

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

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...

Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.