New Drug Application (NDA)

A NDA is the final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S.

New Chemical Entity (NCE)

A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.

Scientific Advice (SA)

Scientific advice is the provision of advice to a company by the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medicine.

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.

Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action

The European Medicines Agency’s initiatives to increase the transparency of clinical trials, and provide an access to summary study results and raw data from trials sponsored by the pharmaceutical industry, as well as any document submitted to the...

Expanding product development to an overseas market can often be difficult to navigate. Thankfully we can help you to find the most effective path to realize your products’ commercial potential.

Kelsey Mower, Associate Director at VCLS will share her...

Adaptive Pathways

Adaptive pathway seeks to maximize the positive impact of new drugs on public health by balancing timely access for patients, with the need to provide adequate evolving information on benefits and risks.

CE Marking

CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable Medical Device Directives (including for In Vitro Diagnostic Device IVD and Active Implantable Medical Device AIMD).