Regulatory Submissions

Validation Services

Ø  Management, planning, protocol writing and execution of validation projects:

Ø  Validation Master Plans

Ø  Facilities, Equipment and Utility Qualification

Ø  Process Validation and Cleaning Validation (CIP/SIP)

Ø  Analytical Method Validation

Ø  Computer Validation


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