Frequently Asked Questions

Access FAQs shared by fellow members from the global lifesciences community around regulations for pharmaceutical, devices, cosmetics, nutrition and consumer health products. Should you have further questions, please drop us an email with your questions. Together, we can help build a healthier world.

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US FDA Compliance

RFD & Pre-RFD Submissions For Combination Products In USA

The healthcare landscape is in a perpetual state of transformation, and as a consequence, there is a noticeable surge in...

MedTech

Medical Device Registration in USA by US FDA

The responsibility for overseeing the regulations of medical device companies involved in the production, repackaging, relabeling, and medical device registration...

MedTech

510(k) Registration with US FDA – Medical Device Registration in USA

Medical devices regulatory compliance is paramount to ensure patient safety and effective product performance. The 510(k) registration process, overseen by...

Biologics

Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)

The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD...

US FDA Compliance

Pharmacovigilance of Vaccines in the USA (US FDA)

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other...

US FDA Compliance

US FDA Regulation of Nitrosamines In USA

Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked significant concern...