GMP BIOPHARMA CONSULT SPRL offer assistance in preparation and support during the EMA and FDA inspections for the following kind of inspections :

            We offer in-depth assistance through a " 3 steps " process :

Inspections are never the same due to the character and behaviour of the inspectors and auditees. For this reason, we provide individual support to our customers.

During FDA inspections, the investigators verifies that the site ( including contract manufactures and contract laboratories ) operates according to the US FDA Regulations and pass successfully the inspection before to supply the US market.

Concerning EMA inspections, local Health Authorities ( member states of EC ) ensure that their inspectors assess according to Eudralex requirements and guidances.