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Regulatory CMC Changes – Challenges and Management

August 30, 2019
Standards

CHALLENGES: Abiding by the national laws and regulations is a necessity for biopharma organizations towards the development, manufacture and selling of their pharmaceutical products. Prior...

Regulatory Intelligence (RI) Unbolts all your Regulatory Challenges

July 12, 2019
Biopharma

Drug development has become highly complex than ever before since the globalization of the life sciences industry. Regulatory Intelligence (RI), which emerged about 15 years ago, is comparatively a...

Luxembourg and The Netherlands benefit from the EU-US Mutual Recognition Agreement for Inspections

June 26, 2019
Standards

Luxembourg and the Netherlands were added into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). FDA confirms the ability of...

European Medicines Agency Seeks Public Opinion on Draft Guideline on Quality Requirements for Medical Devices

June 26, 2019
Medical Device

European Medicines Agency has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month...