Quadramed Services 2

Applications Our experience in clinical trial applications covers more than 25 countries and we are experienced in handling marketing authorisation applications via national, centralised or mutual recognition procedures. Auditing Quadramed has extensive international experience in the field of auditing of manufacturing facilities, clinical trial sites and investigator sites in countries all over the world providing thorough and precise reporting. GCP/GMP/GLP audits *Pharmacovigilance* We are increasingly involved in working alongside some of the major drug companies co-ordinating pharmacovigilance issues in trials and post-market. Integrating our pharmacovigilance efforts into the registration dossier is paramount in the changing regulatory environment.

Applications
Our experience in clinical trial applications covers more than 25 countries and we are experienced in handling marketing authorisation applications via national, centralised or mutual recognition procedures.

Auditing
Quadramed has extensive international experience in the field of auditing of manufacturing facilities, clinical trial sites and investigator sites in countries all over the world providing thorough and precise reporting.
GCP/GMP/GLP audits

Pharmacovigilance
We are increasingly involved in working alongside some of the major drug companies co-ordinating pharmacovigilance issues in trials and post-market. Integrating our pharmacovigilance efforts into the registration dossier is paramount in the changing regulatory environment.

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Areas of expertise Page 2 of 4
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