Importation of Prescription Drugs Final Rule Questions and Answers
Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs…
Read Agency Alert
EMA post-authorisation procedural advice for users of the centralised procedure
This guidance document addresses a number of questions which marketing authorisation holders…
Read Agency Alert
Why Partner with a CRO that has In-House DCT Capabilities?
When you need to outsource your clinical trials and decentralized visits, it…
Read Blog Post
FDA Draft Guidance: Risk Management Plans to Mitigate the Potential...
Industry Draft Guidance Drug shortages pose a significant public health threat as…
Read Agency Alert
IRIS guide for applicants (How to create and submit scientific...
This guide has been produced to show applicants how to use the…
Read Agency Alert
EMA Regulatory and procedural guideline: Public consultation concerning the physical...
The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory…
Read Agency Alert
FDA Issues Final Guidance on Safety Considerations for Container Labels...
FDA has issued the final guidance titled “Safety Considerations for Container Labels…
Read Agency Alert
FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations...
The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences…
Read Blog PostYour 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.
Sign up to receive updates and industry insights