Third Party Audits
We have the necessary expertise for carrying out third-party audits on your behalf to ensure that the Auditee remains in a state of Compliance. Performed around 125audits in the last two years in various countries with our qualified team.
We provide the GMP Auditing Services with a high level of GMP audits of different types of suppliers as per different regulatory standards (i.e. PIC’S, EU GMP, ICH Q7, 21CFR210/211, ANVISA, ISO, etc. for GMP); the audits against the local country standards are also performed by our experienced auditors and Our GMP Audit Reports are also very detailed and acceptable globally.
Following are the types of suppliers we conduct GMP audits for, but are not limited to:
01
CLINICAL Sites
02
API/ API Intermediates; Sterile/ Non-Sterile
03
Formulated Medicinal Products; Sterile/ Non-Sterile
04
Biological, Fermentation-based APIs and Formulation Products
05
Excipients/ Key Starting Materials (KSMs)/ Raw Materials/ Cosmetics
06
Packaging Materials
