Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical
Quality Standard:
non-GMP (ISO 9001:2015)
Pharmacopoeia:
OECD Guideline 117
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical
Quality Standard:
non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. 2.2.32., USP <731>
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP
Therapeutic Modalities:
Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
EP 2.2.14, USP <741>
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
ISO 11737, GMP
Pharmacopoeia:
EP 2.6.12, USP <61>, EP 2.6.13, USP <62>
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP / CGMP
Pharmacopoeia:
USP <81> / Ph.Eur. 2.7.2
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
ISO 17025
Pharmacopoeia:
Ph. Eur. 2.6.30
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical
Quality Standard:
non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. methods: 2.5.9., USP-NF method <461>
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015); GMP (possible, but requires product specific validation)
Therapeutic Modalities:
Biologics
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
EP 2.3.4
