This approach to compliance which we call the cGMP Continuum^SM, provides an adaptable compliance program that will economically and efficiently span the development spectrum from pre-clinical development through commercial API production.

This package is comprised of a controlled document system as well as the necessary controls and operating procedures to track and monitor personnel training, facilities, equipment, components, production / process / laboratory controls, holding and distribution, method validation, process validation, and change control for pre-clinical, clinical, and commercial manufacturing.

The Continuum^SM was developed using references from the FDA and International Conference on Harmonization (ICH) guidance documents, United States Pharmacopoeia (USP), and the Code of Federal Regulations (CFR).

This system provides capabilities for all phases of drug development from handling of raw materials and supplies through production to finished goods handling and shipping.

Services:

• Supplier and client systems auditing
• Compliance program development
• Process validation
• cGMP Continuum^SM