ACG’s international experience has come from working in industry with international manufacturing and product submissions that required a keen understanding of the regulatory environment specific to the entity and product. Client engagements have taken us to the Southeast and Far Asia, and Europe.

The launch into European and Asian markets requires extensive documentation that can tax your current employee resources, especially with tight launch timelines. ACG uses a systematic approach to review current documentation along with interviewing employees on actual procedures to provide the extensive quality manuals and systems documentation, technical files and dossiers needed for medical product submissions, inspections and clinical programs.

We have extensive experience assisting companies with ISO 9001/13485 registration and certification. ACG also provides FDA-required U.S. Agent Services for companies outside the U.S.

Contact us for examples of projects we have completed that are similar in scope and nature to your needs.