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
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
Product Labeling & Listing
	Drug Product Labeling — Rx and OTC
	Drug Product Listing   —Preparation and Submission of FDA Form 2657
	Client Registration   —Preparation and Submission of FDA Form 2656
US FDA Agent Services for Foreign Companies
Due-Diligence Audits

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