cGMP ASSOCIATES, INC.

cGMP Associates, Inc.
CA
United States
ph: 1 (650) 878 9916
info@cGMPAssociates.com

Services

cGMP Associates can help your successful cGMP operations:

Engineering Services
Parenteral and Biochemical Facilities Design
Project Management
Design Qualification
Equipment (Selection, installation, FAT, SAT, Validation, Calibration, Operations)
Utilities (HVAC, Purified Water Systems, WFI, CIP, SIP)
Construction Management
Facility Start-up
Design Control for Medical Device
GMP Process Services
Process and Cycle Development
Operational Metrics (Cost and Capacity Models, Staffing)
Cell Culture and Fermentation, Purification, and Preservation
Sterilization (Steam, EtO, Gamma)
Aseptic Filling, Lyophilization, and Packaging
Isolator Technology
Alternative Dosage form (Blow fill seal, pre-filled syringe)
Medical Device Manufacturing (Drug device combination)
Quality Services
Quality Systems Development
SOP Generation
Specifications Development (QA/QC)
Validation (Equipment and Porcess, VMP, Protocols, Reports)
Preparation of FDA CMC Submission
Quality Audit and FDA Inspections Preparation and Training
Risk and Gap Analysis
Device History File Requirement

Copyright 2009 cGMP Associates. All rights reserved

cGMP Associates, Inc.
CA
United States
ph: 1 (650) 878 9916
info@cGMPAssociates.com