Blog Category: Standards

USA/Canada/UK/EU approved product Labels: Aug 2022

Standards

Below are some analytics and counts of Product labels released from Canada, USA, UK and EU. Following 5 charts give the breakdown of these A. Human prescription labels by Country: ...

Regulatory Intelligence is a key to Quality and Safety

Standards

Organizations often face unforeseen risks when they tread on the uncommon roads of the life science sector. They are often termed as in compliance or compliance issues, which has a direct impact on...

Regulatory Affairs, Regulatory Changes, Regulatory Database, Regulatory Intelligence, Regulatory Intelligence for Biopharma, Regulatory Intelligence for Cosmetics, Regulatory Intelligence for Food Supplements, Regulatory Intelligence for Medical Devices

FDA Issues Guidances on Dual 510(k) and CLIA Waiver Applications

Standards

The US Food and Drug Administration (FDA) finalized two guidance’s providing recommendation for Dual 510(k) and CLIA Waiver by Application Studies. The purpose of this guidance is to help manufacturers...

Regulatory Intelligence (RI) Unbolts all your Regulatory Challenges

Biopharma

In today’s globalized life sciences environment, drug development has become more complex than ever. Regulatory Intelligence (RI)—a relatively new but essential function within global Regulatory Affairs...

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

Standards

Luxembourg and the Netherlands have now been incorporated into the Mutual Recognition Agreement (MRA) between the European Union (EU) and the U.S. Food and Drug Administration (FDA). Through this agreement,...

Blog Category: Standards

USA/Canada/UK/EU approved product Labels: Aug 2022

Regulatory Intelligence is a key to Quality and Safety

FDA Issues Guidances on Dual 510(k) and CLIA Waiver Applications

Regulatory Intelligence (RI) Unbolts all your Regulatory Challenges

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

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