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.
Trust ProPharma Group's Regulatory Sciences team for any an all regulatory-related tasks with our Outsourced Regulatory Department.
How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval.
Learn how to realize large savings and improving operational performance with an out-of-the-box enterprise quality management system.
See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic.
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 novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties…
Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find…
With our mission to improve the health and safety of patients, we are focused on delivering the highest #quality of services throughout…
Whitepapers & eBooks
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.
With pandemic-related schedule delays, supply chain interruptions, and margin reductions, trustworthy data is critical for quality decision making.
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…
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?
Make sure you are prepared when the FDA resumes normal inspection operations. Exact timing is uncertain, but it's coming.
In May 2021, MDR took effect in the EU bringing significant regulatory-related changes.
Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
Accelerating Your Product Through Development: Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
Regulatory Agencies Expect Controls to Be in Place
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.
Gain an Industry Edge With Expertise From ProPharma Group
Get the latest insights and top tips from our experts, delivered right to your inbox.
Have a complex challenge?