Regulatory Submissions

Quality Systems

Ø  Perform cGMP gap analyses

Ø  Preparation for Pre-Approval Inspections

Ø  cGMP and GCP Training

Ø  Generation and implementation of QA/QC systems, policies and procedures

Ø  Clinical Quality Assurance program

Ø  Preparation of Annual Product Reviews (APRs)

Ø  Conduct internal investigations for out-of-specification (OOS) results, deviations, systems errors, etc., as an independent third party.

Ø  Quality Risk Management

Ø  Corrective and Preventive Action system (CAPA)

Clinical and Commercial Supply
Clinical Development
Product Development
Validation Services
cGMP and GCP Audits
Quality Systems