ACE CONSULTING

ACE is staffed with a group of professionals & subject matter experts with experience within the pharmaceutical industry. Over 18 years of validation & compliance experience, from small operations improvement projects, to building quality systems, to full facility validation, to preparing and submitting regulatory applications with FDA (BLA, Orphan Drug Designations, FDA review meetings, PAI inspections). ACE team members have interacted with FDA on several occasions, with BLA submissions, facility design review, to 483/Consent Decree resolution support and 510K regulatory submissions.

Also known as: ACE Validation