GMP BIOPHARMA CONSULT SPRL. has gained experience through the 300 international audits performed within last 20 years including more than 80 audits of aseptic / sterile processes and more than 15 audits of Biological processes. All dosage forms were assessed in-depth.
Certified lead auditor since 1995, we offers an excellent GMP assessment through the main audit steps i.e. preparation, execution including wrap-up and reporting.
Management of international audits requires an excellent knowledge of cGMPs and applicable Regulations. Experiences auditors are able to adapt GMP requirements to small local contract manufacturers which are not in a position to reach Corporate GMP standards of large Pharmaceutical / Biological companies that supply worldwide.