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 2.2.18, USP <651>
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 2.9.7, USP <1216> and JP are harmonized
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:
EP (e.g. EP 2.2.28), USP (e.g. <621>), JP
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:
EP (e.g. EP 2.2.28), USP (e.g. <621>), JP
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 3.2.1 "Glass containers for pharmaceutical use"
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
ISO 11040-4, GMP
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical
Quality Standard:
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:
Ph. Eur. 2.4.8, USP <231>, JP 1.07
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP
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, 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 (e.g. EP 2.2.29), USP (e.g. <621>), JP
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 (e.g. EP 2.2.29), USP (e.g. <621>), JP
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 2.2.43, USP <736>
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 2.2.43, USP <736>
Therapeutic Modalities:
Biologics
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, 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, Small Molecules
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:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
EP 2.2.29, USP <621>
