Quality Systems

Preparation for Pre-Approval Inspections and other audits

cGMP Training - establishment of program and provider of employee training programs

GCP Training - establishment of program and provider of employee training programs

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

Clinical Quality Assurance system program and procedures

Preparation of Annual Product Reviews (APRs) and scientific writing support for CMC

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

Change Control Programs

Vendor Qualification Programs

Product Stability Programs  

Create GMP calibration and maintenance systems

Perform gap analyses

Quality Risk Management establishment and procedures

Corrective and Preventative Action systems (CAPA)

Environmental Monitoring system program and procedures