Discover more about ProPharma Group and how our team of industry-leading experts supports clients at every step throughout the product lifecycle to help improve patient health and safety.

Case Studies

Sponsor Successfully Completes Acquisition After Efficient PMA Submission

How to ideate and execute a creative regulatory and clinical strategy to get a novel Class III device to market…

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…

How to Manage a Drug Product in a Medical Device...

How to effectively support GMP and GDP compliance of a drug product in a medical device environment

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…


Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

How to complete an on-site GMP regulatory audit, by MHRA of an overseas client in Bangladesh in July 2017 to…

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…

Navigating the Generic Drug Application and Approval Process

There are several premarket submission pathways for medical devices. Which one is appropriate for your medical device?

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

Medical devices are regulated by the FDA's CDRH, and there are several premarket submission pathways in the U.S. Which one…



The True Cost of Non-Compliance

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


Free Webinar: Effective FDA Engagement

Learn how to communicate with the FDA effectively so that you don't waste their time and yours.

Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable...

Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response…

Insider Talks – Tips From Qualified Persons for Successful Importation

Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets?

Insider Talks – The Journey of ATMPs From the Discovery...

Gain a better understanding of GMP compliance for ATMPs

Whitepapers & eBooks


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…

What You Need to Know About Regulatory Programs for Expedited...

Differentiating between expedited approval pathways can be tricky. Learn the similarities and differences to help determine the best option(s) for…

Good Science Presented Well Generates Approval

Obtaining marketing approval for a pharmaceutical, biotech, or medical device product requires good data first and foremost. 

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

Learn how to develop a science-focused submission like an expert with these six tips.


Outsourcing of Medical Information Content Creation: Experience of 100 Clients

Learn how ProPharma Group supported 100 different MI clients to assess the options in relation to their requirements in order…

Evolving EMEA MI Service Models

Learn how ProPharma Group delivered a first-class Medical Information Service in a cost-efficient way.

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Learn how ProPharma Group tackled numerous factors that drove the need to consider a dedicated resource for an outsourced model.

Improving Product Quality During Technical Transfers

Is your product quality at risk during a technology transfer? Make sure you are compliant with applicable regulatory requirements and…


On Demand

21 April

A Statistically Leveraged Dose Escalation Study Design (BOIN)

How can we design our dose escalation studies to identify the recommended phase 2 dose in a more efficient way?

April 14, 2022

Insider Talks – Tips to Adapt to Today’s Auditing Environment,...

How can we successfully transition from the old ways to the new improved ways of auditing?

October 28, 2021

Navigating the IVDR Medical Device Regulation

What impact will the changing regulations have in the EU and what do we expect for US markets?

November, 10, 2021

How to Expedite Product Approval in the US and Europe

Could your product be eligible for one of the regulatory programs designed to expedite product approval?

View all Insider Talks >


QP MIA Survey – Progress Self-Assessment

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

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…

EMA Services: Ensure Regulatory Success

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

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.

We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.

Interested in gaining an industry edge? Let us help you stay up to date.

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