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 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/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.

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).

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.