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EMA has extended the deadline to assess the risk of nitrosamine impurities to 31 March 2021. This decision was made based on the reports of the challenges encountered in meeting the original deadline...
Due to the current regulatory landscape that has been created by the COVID-19 pandemic, clinical trials have been disrupted across the globe. To many Sponsors, this may feel like a loss of progress...
Quality & Compliance
The landscape of clinical trials and other clinical development projects has dramatically changed in recent years. Progress made in scientific discovery is paving the way to novel therapies and...
As a response to the COVID-19 Pandemic, the US Food and Drug Administration has recently issued a new guidance document for industry, investigators and institutional review boards titled “FDA...
During the COVID-19 global pandemic, Medical Information (MI) and Pharmacovigilance (PV) teams are providing an extremely valuable service to deliver current and accurate product information to...
Clinical Research Solutions
The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...
With automation becoming more mainstream in science, vast quantities of data are now generated by many organizations every day. This deluge of data is often managed ineffectively, limiting the...
As of March 27, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these recommendations...
New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today's landscape puts sponsors under more pressure than ever before. Clinical trials are becoming...
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...