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)
Pharmacopoeia:
EP 2.2.29, USP <621>
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)
Pharmacopoeia:
EP 2.2.29, USP <621>
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)
Pharmacopoeia:
EP 2.2.30, USP <621>
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical
Quality Standard:
non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, 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)
Pharmacopoeia:
Ph. Eur. 01/2008:20258, USP/NF <730>, USP/NF <233>; Ph. Eur. 2.2.58 and 2.4.20, USP<730> and <233>, JP<2.63> and <2.66>
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:
Ph. Eur. 2.2.57; USP-NF <730>; Ph. Eur. 01/2008:20257, USP <730>
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
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:
USP <191> and Ph.Eur. 2.3.1
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015)
Pharmacopoeia:
USP <776>, USP <695>, Ph. Eur. 2.9.37, Ph. Eur. 5.16, Ph. Eur. 5.9
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
USP <1065>
Therapeutic Modalities:
Biologics, 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. 2.2.24, USP <854> bzw. <197>
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:
PQRI, BPOG, EMEA, USP, FDA guidelines
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP
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 <776>, USP <695>, Ph. Eur. 2.9.37, Ph. Eur. 5.16, Ph. Eur. 5.9
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 2.04
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical
Quality Standard:
non-GMP (ISO 9001:2015)
Pharmacopoeia:
OECD Draft Guideline 122
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical
Quality Standard:
non-GMP (ISO 9001:2015)
Pharmacopoeia:
OECD Guideline 107
