Evaluating your Quality Management System in regard to its composition, implementation, and continued execution is vital to reduce the risk of action from your Notified Body, the FDA, or other Regulatory Agency.
At Auxilium we have combined evaluation tools, 20 + years of experience and Lead Auditor certification to provide our clients with the ability to undertake a comprehensive review of their system and the potential exposure to the risk of field actions, suspension of licenses or registration, or agency action such as FDA Form 483 etc.
There are considerable advantages to retaining the services of a independent third party for your Compliance Evaluation, with a completely independent assessment it is more likey to uncover those issues that have existed through familiarity; that scrutiny is as close to having a Notified Body or FDA inspection without the risk.