Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course" training has been added to ResearchAndMarkets.com's offering. This ...

Ceruvia Lifesciences, a biopharmaceutical company, announced that it has produced the world's first LSD that meets stringent "Current Good Manufacturing Practices" (CGMP) standards required by the FDA ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" training has been added to ...

cGMP production of 186RNL targeted radiotherapeutic beginning in second half of 2022 to support ongoing and future ReSPECT™ clinical trials The FDA indicated agreement with the Company’s proposed ...

Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical's HLA-G targeted exosome ...

MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial ...