How Important is Biostatistics?
The link between statistical methods and healthcare is not a new one,…
Read Blog PostImportation of Prescription Drugs Final Rule Questions and Answers
Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs…
Read Blog PostEMA post-authorisation procedural advice for users of the centralised procedure
This guidance document addresses a number of questions which marketing authorisation holders…
Read Blog PostFDA Draft Guidance: Risk Management Plans to Mitigate the Potential...
Industry Draft Guidance Drug shortages pose a significant public health threat as…
Read Blog PostIRIS guide for applicants (How to create and submit scientific...
This guide has been produced to show applicants how to use the…
Read Blog PostEMA Regulatory and procedural guideline: Public consultation concerning the physical...
The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory…
Read Blog PostFDA Issues Final Guidance on Safety Considerations for Container Labels...
FDA has issued the final guidance titled “Safety Considerations for Container Labels…
Read Blog PostFDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations...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