Our team of subject matter experts can support your clinical development planning in the areas of regulatory, medical/safety, data analytics, and clinical operations.
We can also define elements of the Target Product Profile (TPP) including the indication, population, study design and dosing schedule for first-in-human clinical trials based on:
Cmed can provide the guidance and support required to create the regulatory plan, filing tracker and timeline to ensure a successful submission. This includes support during the review period, including correspondence with and meeting representation with the agency as needed.
It’s never too early to talk to us and we’re always here to help! Don’t struggle, email us at: email@example.com