ADN has a regulatory expertise pointed and recognized in particular in the world of the life sciences.
Consultants ADN are capable to provide you the expertise and the council necessary to all your projects of regulatory conformity, as well in an American context (FDA) as French (AFSSAPS) or European (EMEA).
In particular, we are recognized for many successful projects for the design and remediation of systems to 21 CFR PART 11.
The 21 CFR PART 11 being a directed regulation recording, ADN developed a base of knowledge of the explicitly regulatory recordings likely to be dematerialized.
ADN recommends the directed approach risks for compliance with 21 CFR PART 11. We advise the pharmaceutical laboratories as well, as the software publishers, in their plans for compliance.
