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On April 26th, 2023, a Commission formed by the European Health Union proposed a groundbreaking revision of the EU’s Pharmaceutical legislation, marking the most significant reform in over two...
Clinical Research Solutions
Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain....
Clinical Research Solutions
In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and...
Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices. Compliance...
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new international recognition framework (IRF) for medicines and devices. The IRF will be in place from January 1st,...
The US Food and Drug Administration (FDA) has proposed a new, easy-to-read medication guide for patients known as the Patient Medication Information (PMI)1. The new medical guide will be required for...
In a globalized pharmaceutical industry, ensuring the integrity and reliability of clinical data is of utmost importance. Recently, the Spanish Medicines Agency conducted a comprehensive Good...
Clinical Research Solutions
Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1, we discussed the importance of GxP audits, the different audit types, and why...
What are the keys to building a comprehensive pharmacovigilance (PV) program? Be forward thinking, invest wisely, and question everything. It is so easy as a sponsor of a first-in-human clinical...
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...
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...
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
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...