Blue Bell Consulting is a leading compliance and regulatory consulting firm in China, providing world-class professional services for FDA-regulated industries worldwide
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Blue Bell Consulting has business partnership with Key2Compliance® for years and is the sole authorized agent for all Key2Compliance®¡¯s products in Greater China Area. These products include (1) Play4GMP®, (2) The GMP Handbook for pharmaceutical industry, (3) Quality Systems Handbook for Medical Devices.... (2-28-2012)
cGMP
cGMP Compliance - API/Dosage Form
The cGMP compliance consultation will be conducted in accordance with FDA¡¯s requirements (21 CFR Part 210 & 211 with its interpretations for dosage forms and ICH Q7A for APIs). We will support our clients in building an overall cGMP-compliant quality system in terms of hardware, software, and personnel.
cGMP for Dietary Supplement/Food
cGMP Compliance - Dietary Supplement/Food
The cGMP compliance consultation will be conducted in accordance with FDA¡¯s requirements (21 CFR Part 111 with its interpretations for dietary supplements and 21 CFR Part 110 for foods). We will support our clients in building an overall cGMP-compliant quality system in terms of hardware, software, and personnel.
QSR
QSR/cGMP Compliance - Medical Device
The QSR/cGMP compliance consultation will be conducted in accordance with FDA¡¯s requirements of medical device manufacturers (21 CFR Part 820 - Quality System Regulation and its interpretations). We will support our clients in building an overall QSR/cGMP-compliant quality system in terms of hardware, software, and personnel.
GLP
cGLP Compliance - Preclinical Studies
The cGLP compliance consultation will be conducted in accordance with FDA¡¯s requirements of nonclinical studies (21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies and its interpretations).
GCP
cGCP Compliance - Clinical Studies
The cGCP compliance consultation will be conducted in accordance with FDA¡¯s requirements of clinical studies. We will support our clients in building a cGCP-compliant procedure/program to ensure the integrity of clinical data and to meet the requirement of clients and regulatory authorities.
  • Application for Drugs
  • Application for Medical Devices
  • Application for Foods