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.
How to ideate and execute a creative regulatory and clinical strategy to get a novel Class III device to market…
See how we helped an emerging Biotech Sponsor achieve an enrollment rate and average time to FPI that is well…
How to effectively support GMP and GDP compliance of a drug product in a medical device environment
Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very…
How to complete an on-site GMP regulatory audit, by MHRA of an overseas client in Bangladesh in July 2017 to…
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the…
There are several premarket submission pathways for medical devices. Which one is appropriate for your medical device?
Medical devices are regulated by the FDA's CDRH, and there are several premarket submission pathways in the U.S. Which one…
How to avoid getting your first, second, and third warning letter from a federal agency.
Learn how to communicate with the FDA effectively so that you don't waste their time and yours.
Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response…
Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets?
Gain a better understanding of GMP compliance for ATMPs
Whitepapers & eBooks
Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common…
Differentiating between expedited approval pathways can be tricky. Learn the similarities and differences to help determine the best option(s) for…
Obtaining marketing approval for a pharmaceutical, biotech, or medical device product requires good data first and foremost.
Learn how to develop a science-focused submission like an expert with these six tips.
Learn how ProPharma Group supported 100 different MI clients to assess the options in relation to their requirements in order…
Learn how ProPharma Group delivered a first-class Medical Information Service in a cost-efficient way.
Learn how ProPharma Group tackled numerous factors that drove the need to consider a dedicated resource for an outsourced model.
Is your product quality at risk during a technology transfer? Make sure you are compliant with applicable regulatory requirements and…
How can we design our dose escalation studies to identify the recommended phase 2 dose in a more efficient way?
April 14, 2022
How can we successfully transition from the old ways to the new improved ways of auditing?
October 28, 2021
What impact will the changing regulations have in the EU and what do we expect for US markets?
November, 10, 2021
Could your product be eligible for one of the regulatory programs designed to expedite product approval?
Use this readiness questionnaire to assess the current state of your progress.
The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your…
Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
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