Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline

Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations.

Marketing Authorization Holders (MAHs) must perform a risk evaluation of their medicinal products containing chemically synthesized Active Pharmaceutical Ingredients (APIs) to assess adherence to nitrosamine regulations. The risk evaluation of all products must be concluded by March 31, 2021, at the latest.

Find out how ProPharma Group experts expediently satisfied a request for a risk assessment essential to meeting nitrosamine regulatory requirements.

Case Study



The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...


Free Webinar: Effective FDA Engagement

FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...


Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...