Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report offering invaluable information about the pharmaceutical regulatory affairs in the EU and US.

Pharmaceutical Regulatory Affairs in the EU and US helps the reader implementing a regulatory strategy that will guide the company’s product from development to launch, in both the EU and US.
Helping the reader to discover the origins and purposes of pharmaceutical regulation, and the principal regulatory bodies it explains how they affect the reader’s role as a regulatory affairs professional.

The report will allow the reader to:

• Know how to ensure pre-clinical and clinical studies comply with key EU and US regulations, including GLP (Good Laboratory Practice), GCP (Good Clinical Practice), the EU Clinical Trials Directive and FDA (Food and Drug Administration) requirements

•  Learn the fundamental procedures, issues and initiatives (including the FDA Critical Path) that will have an impact on the company’s regulatory strategy

• Gain awareness of other procedures in order to manage the approval process for a range of product types (including biosimilars, generics and variations).

Pharmaceutical Regulatory Affairs in the EU & US

Report Buyer product ID: SCR00010
Report Buyer category: Pharma & Healthcare