Regulatory Affairs is responsible for interactions with regulatory authorities and has a role in good clinical practice and interacts with:

Manufacturing Clinical Development
Research Clinical Operations
Toxicology Drug Safety
Finance and Commercial
Program and Project Management Marketing

Wikipedia gives a good overview of Regulatory Affairs and useful links.

Regulatory Authorities

United States Food and Drug Administration (FDA)

Health Canada

European Medicines Agency

Japan – Pharmaceuticals Medical and Devices Agency

India – Central Drug Standards Control Organization (CDSCO)


FDA Guidances

FDA Guidances (Drugs)

International Conference on Harmonisation (ICH)

ICH official website

Regulatory Affairs professional organizations

Regulatory Affairs Professionals Society

The Organization for Professionals in Regulatory Affairs (TOPRA)

Regulatory Affairs Consulting Organizations

BioDirect, Inc

Biologics Consulting Group

Era Consulting

Intertek Pharmaceutical Regulatory Affairs Services

Ivowen Limited – Specialize in generics

Lachman Consultant

PhaRA Pharmaceutical Regulatory Affairs

Pharmaceutical Development Services


Real Regulatory

TopPharm Consulting (Poland and EU)


Speid & Associates, Inc

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