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cGMP Associates is the key to your cGMP operations success.  Full Services Consulting    

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CONTACTS AT CGMPASSOCIATES.COM

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1

cGMP Associates, Inc. - Publications

http://www.cgmpassociates.com/publications

CGMP Associates, Inc. 1 (650) 878 9916. Moist Heat Sterilizer Design, Commissioning, and Maintenance. PDA Technical Report, New Tech Repor. ASME BioProcessing Equipment Standard. Leachables Evaluation for Bulk Drug Substance. PDA Journal of Pharmaceutical Science and Technology, April 2009. A Practical Approach to Steam Autoclave Cycle Development. Journal of Validation Technology, February 2007. A Computer-Controlled Autosyringe System using an IBM PC. Laboratory Microcomputer, 1989. CGMP Associates, Inc.

2

cGMP Associates, Inc. - Services

http://www.cgmpassociates.com/services

CGMP Associates, Inc. 1 (650) 878 9916. CGMP Associates can help your successful cGMP operations:. Parenteral and Biochemical Facilities Design. Equipment (Selection, installation, FAT, SAT, Validation, Calibration, Operations). Utilities (HVAC, Purified Water Systems, WFI, CIP, SIP). Design Control for Medical Device. Process and Cycle Development. Operational Metrics (Cost and Capacity Models, Staffing). Cell Culture and Fermentation, Purification, and Preservation. Sterilization (Steam, EtO, Gamma).

3

cGMP Associates, Inc. - Home

http://www.cgmpassociates.com/home

CGMP Associates, Inc. 1 (650) 878 9916. CGMP Associates is the key to your cGMP operations success. CGMP Associates is a consulting firm that can provide expertise in Chemistry Manufacturing and Control (CMC) related services for the pharmaceutical, biopharmaceutical, and medical device manufacturing industries. Each of our principals have over 20 Years Experience in pharmaceutical, biopharmaceutical, and medical device industries. CGMP Associates, Inc. 1 (650) 878 9916.

4

cGMP Associates, Inc. - About Us

http://www.cgmpassociates.com/about_us

CGMP Associates, Inc. 1 (650) 878 9916. Victor Tsui, CEO. High Diploma in Chemical Technology The HK Polytechnics University. MS in Engineering University of Wisconsin. Licensed professional engineer in Chemical Engineering. Project Management Certificate from UC Berkeley. ASME, PDA Editor, Moist Heat Sterilizer Design Technical Report. Ionics (GE), Therma, Elan/Solstice, VaxGen, Anesiva. Water Systems, Piping and HVAC design and installation, Equipment qualification, Steam Sterilization. 1 (650) 878 9916.

5

cGMP Associates, Inc. - Project Experience

http://www.cgmpassociates.com/project_experience

CGMP Associates, Inc. 1 (650) 878 9916. Powder Pharma (HK) - Zingo needle free injector drug/device. Wanbang Anesiva (China Joint Venture) - Drug Device Assembly, Xuzhou, China. CGMP Associates, Inc. 1 (650) 878 9916.

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cGMP Associates, Inc. - Home

CGMP Associates, Inc. 1 (650) 878 9916. CGMP Associates is the key to your cGMP operations success. CGMP Associates is a consulting firm that can provide expertise in Chemistry Manufacturing and Control (CMC) related services for the pharmaceutical, biopharmaceutical, and medical device manufacturing industries. Each of our principals have over 20 Years Experience in pharmaceutical, biopharmaceutical, and medical device industries. CGMP Associates, Inc. 1 (650) 878 9916.

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