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)
Japan – Pharmaceuticals Medical and Devices Agency
India – Central Drug Standards Control Organization (CDSCO)
FDA Guidances
International Conference on Harmonisation (ICH)
Regulatory Affairs professional organizations
Regulatory Affairs Professionals Society
The Organization for Professionals in Regulatory Affairs (TOPRA)
Regulatory Affairs Consulting Organizations
Intertek Pharmaceutical Regulatory Affairs Services
Ivowen Limited – Specialize in generics
PhaRA Pharmaceutical Regulatory Affairs
Pharmaceutical Development Services
TopPharm Consulting (Poland and EU)
Please contact us if you are interested in being listed here.