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Regulatory Sciences
On September 25, 2025, FDA posted an additional 11 Untitled Letters from the cohort of letters issued on September 9, 2025, bringing the total number of compliance letters directed toward...
Quality & Compliance
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company's needs. Every company knows timing is critical to success. But...
Regulatory Sciences
The Agency’s Advertising Enforcement Letters Reveal Shifting Regulatory Priorities On Tuesday, September 16, 2025, FDA posted 40 Untitled Letters and 8 Warning Letters directed at prescription drug...
Regulatory Sciences
On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The...
Quality & Compliance
The Crossroads of Global Compliance For medical device and diagnostic companies operating in today’s global marketplace, success depends on more than just innovative products — it hinges on a...
Regulatory Sciences
On September 4, 2025, FDA announced a sweeping policy change: the real-time release of Complete Response Letters (CRLs); a continuation of FDA's July 10, 2025 publication of previously undisclosed...
Regulatory Sciences
In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...
Quality & Compliance
When we meet with life sciences clients (especially small/mid-sized companies), Project Management (PM) is very rarely an area of importance. It is almost consistently an afterthought. Clients are...
Medical Information
In the pharmaceutical and medical information space, contact centers serve as a vital bridge between healthcare professionals, patients, and the companies that manufacture and distribute...
Regulatory Sciences
Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...
Regulatory Sciences
Pharmaceutical, biotech, and MedTech companies invest significant time and resources into developing promotional materials, only to face avoidable delays during the Medical, Legal, and Regulatory...
Medical Information
In today's highly regulated pharmaceutical industry, Medical Information (MI) services are expected to do more than respond to inquiries; they must provide accurate, balanced, and scientifically...
Regulatory Sciences
Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...
Pharmacovigilance
Previously, we outlined the critical components to be considered when starting a clinical trial program (Safety Services: A Critical Component of Clinical Trials). In this second installment we'll be...
Clinical Research Solutions
Clinical trials are complex, resource-intensive, and heavily regulated endeavors that span months to years. For many pharmaceutical, biotechnology, and medical device companies, navigating this...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...