regulatory sciences

Scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes

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The World’s Leading Regulatory Science Consultancy

ProPharma's aim is to help your business succeed, by working to streamline the pharma/biotech/medical device regulatory process. Our experienced regulatory consulting and compliance team commands an unparalleled breadth and depth of knowledge pertaining to the US and European regulatory frameworks and can work with you to accomplish your business objectives. Using our deep science knowledge, our regulatory team develops and executes detailed strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome, whether that is a submission or a meeting. We also support post-authorization regulatory pharma/biotech/medical device operations including product launch, publications review, line extensions (LEs), and CMC changes. We maintain your products' optimal regulatory status throughout its lifecycle. Our track record of success in both the US and Europe is unmatched. As the only true global consultancy our pharmacologists, toxicologists, chemists, and clinicians have helped hundreds of small and large firms move their products from one regulatory hurdle to the next.

All Regulatory Science Solutions

Our regulatory affairs experts create detailed strategies to move your product through all regulatory stages with exceptional care.

 

Submissions & Applications

ProPharma offers expert guidance and regulatory submission support throughout the entire development and launch processes. With over 35 years of experience, we will plan and coordinate every detail of a clear and complete US/European submission. We’ll utilize our extensive regulatory and scientific experience engaging with the FDA to optimize the submission process. We provide consulting services for key FDA regulatory submissions, including:

investigational-new-drug-submission

  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Orphan Drug Designation (ODD) and
  • Biologics License Applications (BLA)
  • Investigational Device Exemptions (IDE)
  • 510 (K) submissions and
  • Pre-Market Approval (PMA)

Our European groups support:

  • Scientific Advice meetings
  • Paediatric Investigation Plans (PIP)
  • Orphans Drug Submissions (ODD)
  • Marketing Authorization Applications (MAA)
  • European Medical Device Regulation
  • CE filings

Investigational New Drug (IND) Submission Guidance

Obtaining Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) is the first step towards beginning your clinical trials in the United States. Getting here required hard work and a great Pre-IND Meeting strategy, but you still need FDA clearance on your IND application before you can ship your drug across state lines and begin clinical trials.

The sooner you can begin your clinical trials, the sooner your product will be on the market. To prevent any hiccups in this process, your final IND submission must be error-free and contain all required information including animal pharmacology and toxicology studies, and manufacturer, and investigator information, along with detailed protocols for your upcoming clinical trials.

No matter where you are in the IND application or submission process, our IND consultants can provide guidance to assist with the remaining steps.

New Drug Application (NDA) Submission Guidance

You have successfully navigated almost all the milestones required to obtain FDA approval and are finally ready to approach the final steps in the process. Before your product can be marketed in the United States, you must obtain NDA approval from the FDA.

Choosing the Right Regulatory Pathway: 505(b)(1) vs. 505(b)(2)

Preparing an NDA is a very rigorous, time-consuming, and expensive process, and the first step is deciding which regulatory pathway to follow. For small molecule therapeutics, there are two regulatory pathways to choose from when preparing an NDA: 505(b)(1) and 505(b)(2). Choosing the right one is critical to the success of your submission. What is the difference between the two?

  • 505(b)(1) is the traditional regulatory pathway for NDA submissions. The 505(b)(1) pathway is used when seeking a new drug’s approval without relying upon non-proprietary clinical or pre-clinical studies. Sponsors submitting a 505(b)(1) NDA must demonstrate the drug’s safety and efficacy and are required to conduct all studies necessary to do so
  • The 505(b)(2) pathway is used by Sponsors seeking approval of a new drug, which is made up of active ingredients similar to a previously approved drug or in which there are scientifically credible published studies. When submitting a 505(b)(2) NDA submission, Sponsors can rely, at least partially, on data used to support the Agency’s findings of safety and effectiveness related to a similar product that has been previously approved by the FDA


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ANDA Consulting Expertise

You have developed a generic drug product. To market the product for sale in the United States, an ANDA must be reviewed and approved by the FDA.

Before your Abbreviated New Drug Application (ANDA) is submitted to FDA, you must be certain your product is bioequivalent to the Reference Listed Drug (RLD). Doing this can be challenging, but ProPharma’s experts are here to help. We will assist you through the entire ANDA submission and approval process with the FDA, from ensuring your product demonstrates bioequivalence to developing a submission strategy and compiling and submitting your application.

anda-consulting-expertise

After determining that your product meets these requirements, ProPharma will review all relevant documentation and work with you to develop an ANDA filing plan that balances risk, speed to approval, and cost. We will then produce your ANDA submission, completing all relevant modules. For each module, we help as follows:

  • Determine the required content
  • Examine the content for suitability
  • Edit/write/translate as necessary to complete the module

We will compile and edit the completed ANDA, ensuring it is of sufficient excellence to meet the FDA’s rigorous standards and is thus ready for submission. When the document is finalized, we will convert it to the Electronic Common Technical Document (eCTD) format, so it is ready to be filed electronically with the FDA. If requested, ProPharma may also act as your Agent and submit the finished ANDA in eCTD format to the FDA.

Orphan Drug Designation (ODD) Submission Guidance

Obtaining orphan designation can be challenging, and requires knowledge about disease prevalence and the appropriate regulatory process. We will work with you to determine whether your product is eligible for orphan designation, using all relevant documents, including product information, scientific articles, public-domain information, disease prevalence data, etc., to help make an informed decision. If we recommend proceeding with the application, we will work with you to develop and submit a complete application that builds upon the information obtained through our evaluation of the research.

Biologics License Application (BLA)

biologics-license-application

A BLA is generally submitted after an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) and after the appropriate studies have been conducted. A biologics license application applies to vaccines and other allergenic drug products, blood products, and cellular and genetic therapies. Planning and executing this process is an extremely involved and complex initiative requiring coordination, diligence, and domain expertise in several areas. We've helped many companies—big and small—plan and navigate the BLA process successfully, on time and on budget.

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Regulatory Authority Meetings

To achieve your goals in a regulatory authority meeting, the interaction must be carefully planned and flawlessly executed, leaving the regulatory agency with a good impression of your product and company. This requires expert guidance from professionals who have prior regulatory experience and know the appropriate time to request a meeting, what is needed to prepare the necessary paperwork, what to expect when meeting with the FDA or EMA, and what steps should be taken post-meeting. To the best extent possible, any meeting with a health authority should end in clarity. Our extensive experience managing communications with the various worldwide regulatory authorities can help reduce time to market and conserve patent life.

Pre-IND Meeting Planning

You have been planning for this moment for so long, and it is finally here. You’re ready to begin testing your drug in humans but are not sure that the design of your studies is valid, or maybe you’re looking for confirmation that your rationale is sound. You need to attend a Pre-IND Meeting with the FDA. The Pre-IND Meeting will allow you to communicate with the FDA early in the process, getting feedback on your drug development program before moving forward.

ProPharma will guide you through the entire Pre-IND process – from submitting the initial FDA meeting request and supporting briefing document through preparing for and executing the meeting. Our goal is to help you meet this critical milestone.

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Types of INDs

INDs fall into two categories, commercial INDs and research INDs:

Commercial IND: Commercial INDs are used when the Sponsor intends to bring the drug to the open market. This means commercial INDs can apply to drugs created by non-profit groups who intend to eventually put the drug on the open market. The application process and timeline for a Commercial IND is much longer and more complex than for a Research IND.

Research IND: Research INDs are used when the intention is to prove efficacy for a new indication of an already approved drug. Research IND applications are submitted by physicians, and with a process that is less complex than Commercial INDs. For example, Research INDs typically involve fewer investigators and are often done at a single testing site.

How to Submit an IND Application

Your IND application will request authorization from the FDA to administer an investigational drug/biological product to humans and must be approved before you transport your product across state lines to clinical sites. The requirements for an IND submission are complicated and can be hard to understand. For example, Commercial IND applications must be submitted through the FDA’s Electronic Submissions Gateway, while Research IND applications can be submitted in paper form to the relevant address. This is just one example of the complexities within the IND application and submission process.

As such, working with an experienced IND consultant helps to ensure you’re equipped and on track. ProPharma will work with you to make sure your IND application meets the FDA’s stringent IND filing requirements and contains all the necessary components.

IND Filing Requirements

Each IND application should include the following:
  • Form FDA 1571 (IND application cover letter)
  • Form FDA 1572 (Investigator’s statement)
  • Form FDA 3674 (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)
  • Table of contents
  • Introductory statement
  • General investigational plan
  • Investigator’s brochure
  • Protocol(s): study protocol(s), investigator data, facilities data, Institutional Review Board (IRB), Chemistry, manufacturing, and control (CMC) data, including environmental assessment or claim for the exclusion (assuming the draft of CMC information exists)
  • Pre-clinical: pharmacology and toxicology data
  • Clinical: previous human experience
  • Additional information to support the IND filing

Together, we will carefully review the IND application, and our staff will provide you with a final copy that is FDA ready. The IND application will go into effect 30 days after the FDA receives the application (unless subject to a clinical hold), or earlier if the agency notifies the Sponsor that clinical trials can begin.

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End of Phase 2 (EOP2) Meetings

Following your Phase 2 clinical trials, you will need to review and obtain agreement from the FDA on your study designs for Phase 3. This is the purpose of the End of Phase 2 (EOP2) Meeting with FDA, in which you’ll need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.

During this meeting, FDA will determine whether it’s safe to proceed to Phase 3. They will evaluate your Phase 3 plans and protocols along with your existing studies to assess effectiveness, and they’ll note if any additional information is necessary to support the marketing application. The End of Phase 2 Meeting is a critical milestone in your development program, so it’s important to prepare to make sure you leave with plenty of helpful feedback.

Who is Eligible for an End of Phase 2 Meeting?

The EOP2 Meeting with the FDA is typically for Investigational New Drugs (INDs) that involve new molecular entities or major new uses of marketed drugs. However, a Sponsor of any IND may request an EOP2 Meeting with FDA in preparation for Phase

When Should the End of Phase 2 Meeting Occur?

As the name implies, the EOP2 Meeting should occur at the end of Phase 2 clinical trials. Furthermore, the meeting should occur before serious resource commitments are made towards Phase 3. However, the EOP2 Meeting should not delay the transition from Phase 2 to Phase 3, which is why planning and preparation are critical.

Preparation for End of Phase 2 Meeting

To move you to the next clinical trial phase, ProPharma will diligently work with you to prepare for the EOP2 Meeting.

FDA Advisory Committee Meetings

We have pioneered a unique marketing-based approach to FDA Advisory Committee Meetings to get you through this high-stakes interaction. Each Advisory Committee is different and has specific needs and concerns, which should be kept in mind as you discuss your product.

After learning about key issues in your product’s history and identifying critical issues in your current application, ProPharma will create a strategy for your meeting that is predicated on concerns likely to be raised by the FDA Advisory Committee, and the data necessary to address them. With this strategy in place, we will help you to prepare a slide presentation that presents all information in a complete, understandable, and simple manner. Since most Committee members will review this information before the meeting, we must make it easy for them to understand why approval is rational. Next, we will make sure all participants are prepped for the meeting by conducting a rehearsal to train the speakers. Finally, we will attend the meeting with you, along with select Key Opinion Leaders (KOLs), providing data and presentations as needed during the meeting.

Pre-NDA Meeting Guidance Consulting

Thousands of hours and millions of dollars have gone into assuring a safe and effective product. The next and final step is Food and Drug Administration (FDA) approval and the key to achieving this is a perfectly executed Pre-NDA Meeting.

If you’re not sure where to start, we’ll explain everything you need to know about Pre-NDA Meetings with the FDA. For additional guidance with your New Drug Application, you can also contact our expert NDA consultants to help navigate the regulatory landscape.

 

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What is the Purpose of the Pre-NDA Meeting?

A Pre-NDA Meeting enables Sponsors and the FDA to ensure your New Drug Application (NDA) submission is well-organized and set up for success. The Pre-NDA Meeting should generally occur no less than 60 days before the submission date. Prior to the meeting, Sponsors should prepare for typical Pre-NDA Meeting questions over areas such as the formatting of the submission and inquiries regarding the evidence of effectiveness. During the Pre-NDA Meeting with the FDA, the Sponsor will discuss the format and content of the anticipated NDA, with a specific focus on the presentation of the data that will be submitted.

ProPharma NDA consultants specialize in various disciplines and stay abreast of changing trends and current events. In short, we bring a unique and extensive range of knowledge and skills to the table, which is what you need to achieve a successful Pre-NDA Meeting and NDA submission.


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Regulatory CMC

Chemistry, Manufacturing, and Controls (CMC) Advice and Management

CMC involves defining manufacturing practices and product specifications that must be followed and met to ensure product purity and consistency between batches. CMC begins after a lead compound is identified through drug discovery and continues through all remaining stages of the drug development lifecycle.

Before you’re ready to test your medicinal product on humans, you must develop a CMC process to ensure quality manufacturing standards have been established. This information is required in Module 3 of the clinical trials application (CTA), such as the investigational medicinal product dossier (IMPD) in Europe and the FDA’s investigational new drug (IND) application in the US, as well as EU marketing authorization applications and FDA NDAs or biologics license applications (BLAs). The primary objective of CMC is to assure the quality of the finished product during all phases of development.

CMC Practices

cmc-practices

All companies with investigational products are required to follow the specific details of their CMC process for every phase of the product lifecycle, including lifecycle management activities (e.g., technology transfer and LEs). A critical element is knowing which steps and variables in the manufacturing process need to be controlled and why to obtain a comprehensive understanding of the necessary CMC strategy. If CMC practices are not followed or if they do not meet current regulatory requirements, the marketing authorization will be considered non-compliant and will be withdrawn.

Regulatory requirements are constantly evolving, so let us help you update your CMC strategy to stay compliant with current guidance from the agencies.

Science-Focused Regulatory CMC Consulting

Working with a global partner experienced in regulatory strategy and CMC development can help you appropriately analyze and document the manufacturing processes, active substance and drug product characteristics, and testing to ensure the product is safe, effective, and consistent. From early-stage development and at every point through commercialization, ProPharma partners with you to tackle complex CMC development challenges.

We help ensure the regulatory authorities see the control and robustness of your process and product from both a documentation and operational perspective. Our regulatory CMC consulting experts are scientists first and foremost. As your CMC consulting partner, we can smooth the path to marketing authorization application (MAA)/new drug application (NDA) approval and commercialization, balancing cost, risk, and speed to help you ensure quality manufacturing and effective controls for the health and safety of patients.

  • Unmatched global reach means we can work with you to prepare your marketing applications (MAA or NDA) in parallel, saving you time and money
  • Science-first approach to understanding your product, combined with first-hand insights of regulatory expectations and requirements, help support the successful design of your CMC plan — including process and formulation development, analytical development identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CPP), developing control strategies, establishing quality testing methods, and reviewing validation protocols and reports
  • Our 35+ years of providing regulatory sciences services means we’ve seen how submission requirements and expectations are constantly evolving. Our frequent contact and extensive experience with regulatory agencies ensure you will be following the latest FDA and EMA/national agencies guidance
  • Deep domain expertise of the regulatory world means that we can interpret the regulatory landscape and translate this into a successful regulatory CMC strategy. We can also provide scientific advice and prepare, coordinate, and participate in meetings with the regulators of interest

 

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Promotional Review

Compelling, Compliant Information to Successfully Promote Your Product

Any activity undertaken, organized, or sponsored by a company that is intended to promote the prescription, recommendation, supply, administration, or consumption of a pharmaceutical, biotechnology, or medical device product may be considered promotional material. Such marketing material can be available through various methods of communication, including ads and brochures, mailings, websites, congress materials, and presentations from spokespersons or medical representatives. This content must follow strict European Union (EU) and national guidelines relating to the promotion of medicines, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) code of practice.

During every step of the product lifecycle, your product’s messaging to healthcare professionals and patients must always be clear, compelling, and fully compliant. Whether you’re developing print materials, websites, digital sales aids, or patient support materials, ProPharma has the knowledge and experience to help ensure all of your marketing materials are balanced and aligned with all regulatory and ethical codes.

Promotional Material Objectives

Promotional material has two equally important objectives: (1) it must achieve business goals, and (2) it must comply with regulatory constraints. Any promotional material must always accurately present both risks and benefits, and all claims need to be truthful, substantiated, and non-misleading.

At ProPharma, our experts can ensure that you adhere to applicable laws, regulations, and industry standards while maintaining the highest ethical standards for reporting of your sales, marketing, and promotional material in the EU/European Economic Area (EEA). We can help with all aspects of creating and publishing promotional material, including:

  • Regulatory review of promotional and non-promotional materials and activities in accordance with the respective ethical codes in the local country
  • Creation and update of Abbreviated Product Information (API) texts
  • Support in setting up a routine for local review of promotional materials in the local country
  • Advice on general questions regarding the local ethical codes

Regulatory Operations

Reduce Time to Market with a Smooth Application Process

After conducting clinical studies and obtaining necessary data, the next step is to prepare for submission of the marketing authorization application (MAA) by compiling the dossier and performing a gap analysis to ensure that all regulatory requirements are fulfilled. Any national requirements must also be adhered to, and the dossier can then be published and submitted to the relevant authorities.

The right strategy and knowledge are critical to determining which of the European Union (EU)/European Economic Area (EEA) filing procedures are applicable or preferred. In the assessment process, it is important to know the timelines and have a close dialogue with the health authorities. With successful dossier preparation and efficient submission and procedural management, you will avoid unnecessary delays and have a faster time to market for your product.

After approval of your initial application, you need to remain compliant with all regulatory requirements (e.g., commitments, variations, renewals) to keep the product on the market. A strategic approach to lifecycle management is also valuable in maximizing the potential of the product (e.g., line extension and additional indications). Our regulatory experts are scientists with a deep understanding of the intricacies of regulatory operations across all phases of the drug development lifecycle.

Regulatory Operations Expertise

ProPharma will serve as a true extension of your team and help you with every aspect of your application, from pre-authorization through commercialization. Our regulatory operations experts have extensive knowledge and experience in project management as well as in submission and procedural management and can partner with you at any point in the process to collect and organize the data, publish it in Electronic Common Technical Document (eCTD) format, send registration files, correspond with the right authorities at the right time, and compile, analyze, and prepare additional data needed to answer questions that arise during assessments.

 

regulatory-operations-expertise

 

Here's how we can help you and your team:

  • Dossier Compilation and Publishing: We assist with regulatory strategy development as well as writing and preparation of dossier modules to make sure that all regulatory requirements are fulfilled. Through gap analysis, our experts can find and resolve any issues prior to submission. Our publishing team prepares your application for submission to the relevant health authorities
  • Submissions and Procedural Management: We support the submission of your application and guide you through the necessary steps of the assessment procedure, keeping you fully informed on your application status and following up with authorities to ensure that any questions are properly responded to and that the application process runs smoothly
  • Act as Local Contact with Health Authorities: We understand what registration documentation or variational action is required by the different health authorities and how it should be presented. We handle the contact and dialogue with regulators to smooth the application process for you


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Regulatory Science Experts

lucy radley headshot

Lucy Radley

Senior Vice President
European Regulatory Development

Matthew Weinberg

Matthew Weinberg

President
Regulatory Sciences

eric fish headshot

Eric Fish

General Manager
NDA Partners

marla scarola headshot

Marla Scarola

Senior Vice President
Regulatory Process Management

steve jensen headshot

Steve Jensen

Executive Vice President
Head of U.S. Regulatory Sciences

nick littlebury headshot

Nick Littlebury

Vice President
European Regulatory Operations

Tracy Rockney

Tracy Rockney

Executive Vice President
Promotional Review & Labeling Services

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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...

Case Study

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

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

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

February 1, 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

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

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...

Case Study

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

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

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

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

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

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

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

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

October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

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

Case Study

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

February 1, 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

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...

Videos

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...

Case Study

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

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.  

Case Study

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...

Videos

October 15, 2021

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

Case Study

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

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.  

Case Study

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

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 1, 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.

Flyers

October 14, 2021

EMA Services: Ensure Regulatory Success

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

Flyers

February 1, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers

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

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

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers

October 4, 2021

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

Reduce Launch Timeline and Improve Business Efficiency

Flyers

February 1, 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.