Conducting Audits Worldwide according to EudraLex Volume 4, ICHQ7 and 21 CFR Parts 210 and 211, GDP, GLP and CFR 111 as well as Food Supplements.
Audits at

Key Starting Material Factories,
Food Supplements,
Active Substance
Finished Dosage Forms Plant (Oral and Liquid)

CAPA Evaluations
Follow-up Audits to ensure Implementation of CAPAs
Spot Checks and Fore cause Audits
Preparing Sites for EDQM / EU Authority Audits
Accompanying EDQM / EU Authority Audits
In-House GMP Training
Consulting in Transferring Analytical Methods
Consulting in DMF preparations
Preparing Risk Assessments
Working with Suppliers to solve Quality Issues