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 2.2.2, USP <631>, ChP 0901, DIN 6162, ISO 6271, ISO 11664, ASTM E308, ASTM D1925, AOCS Cc13e, BS 684, ADMI, ICUMSA, EBC, ASBC, Hess-Ives
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:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
USP <1112>, EP 2.9.39
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. general method 2.5.32, USP-NF general method <921>
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. general method 2.5.32, USP-NF general method <921>
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. general method 2.5.12, USP-NF general method <921>
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, Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
EP 2.9.5
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 2.2.37, USP <735>
Therapeutic Modalities:
Biologics, Small Molecules
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:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP
