Resources for Life Sciences Compliance & Validation
Your central hub for publicly available regulatory guidance, industry standards, and digital validation resources.
Regulatory Agencies & Guidance
FDA – U.S. Food & Drug Administration
MHRA – UK Medicines & Healthcare Products Regulatory Agency
FDA – U.S. Food & Drug Administration
Summary: Access public GxP regulations, data integrity guidance, inspection summaries, and new Computer Software Assurance materials.
EMA – European Medicines Agency
MHRA – UK Medicines & Healthcare Products Regulatory Agency
FDA – U.S. Food & Drug Administration
Summary: Provides EU GMP guidelines, Annex 11, scientific papers, and public assessment reports.
MHRA – UK Medicines & Healthcare Products Regulatory Agency
MHRA – UK Medicines & Healthcare Products Regulatory Agency
MHRA – UK Medicines & Healthcare Products Regulatory Agency
Summary: Offers data integrity guidance, GMP/GDP updates, and inspectorate publications.
WHO – World Health Organization
China National Medical Products Administration
MHRA – UK Medicines & Healthcare Products Regulatory Agency
Public GMP guidance, quality system frameworks, and technical reports.
HPRA – Health Products Regulatory Authority
China National Medical Products Administration
China National Medical Products Administration
Public guidance, compliance updates, and regulatory information for medicinal products, medical devices, and controlled activities in Ireland.
China National Medical Products Administration
China National Medical Products Administration
China National Medical Products Administration
Official regulations, safety notices, drug and device guidance, and quality updates for the Chinese pharmaceutical and biotechnology sectors.