Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical
Quality Standard:
ISO 17025
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
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, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and 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. methods: 2.2.19, 2.2.20, 2.5.1, 2.5.2, 2.5.3, 2.5.4, 2.5.5, 2.5.6, 2.5.11, 2.5.29, 2.5.30, USP-NF method <541>, 2.5.7, 2.5.36
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. method 2.5.10., USP-NF method <471>
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
European Standard EN 12260
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. method 2.2.44., USP-NF method <643>
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
USP <1050>, USP <1237>
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:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP
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. 01/2009:20201
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and 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)
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, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
EP 2.2.25, USP <857>
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, Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. JP, USP, others on request
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
EP 2.2.10, USP <912>, EP 2.2.9, USP <911>, EP 2.2.8
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 2.2.1, USP <855>
