Audits are crucial to meeting international compliance standards and succeeding in any product development. We offer extensive support to our customers in regulated markets to enable a successful audit based on EU-GMP regulations.
- 3rd party audits of API suppliers and CMOs
- Plant audit support for APIs, intermediates and industrial chemicals to verify extent of conformity and implementation of GMP
- Our audit partners are highly experienced in auditing pharmaceutical suppliers locally and internationally.
- We assess the competence of the management system to ensure conformity with GMP requirements.
- We investigate unusual events or incidents to determine facts, recreate events, and/or determine causes.
- We recognize areas for potential improvement.
- Need of the day: remote/desktop audit
How do we assist?
Over the past three decades, ExSyn has proficiently managed more than 500 GMP and paper-based audits.