Staying in Compliance:
Drugs and Biologics

Let us help you solve a problem before you encounter it.

We offer:

General CGMP Compliance Support

	CGMP Audits and Assessments — Systems Approach
	Resolution of CGMP Problems
	On-Site Training Programs
	Quality System Development
	Documentation and Records
	Vendor Evaluation
	Validation of Processes for both Manufacturing and Laboratory
	Development or Critique of SOPs

Product Labeling & Listing

	Drug Product Labeling — Rx and OTC
	Electronic Labeler Code Request
	Electronic Facility Registration
	Electronic Drug Product Listing

Computer Validation

Part 11 Compliance

Pre-Approval Inspection (PAI) Issues

	Strategy Development for PAI Readiness
	FDA Style "Mock" Inspections
	Evaluation of Control Systems
	Training
	On-site Consultation During PAI

Quality Assurance and Quality Control

	Organizational Structures for QA/QC Units
	Deviation Investigation Problem Solving
	Responsibilities and Activities

API and Chemical Intermediate CGMP Evaluation

	Documentation and Records
	In-Process Controls and Validation
	Reprocessing and Reworking
	Laboratory Controls
	PAI Support

US FDA Agent Services for Foreign Companies

Due-Diligence Audits

Please contact us for additional information or to get help now!