Regulatory Affairs

Keyrus Biopharma provides expert support on all pre- and post-authorisation regulatory activities, helping you get your products to the market and successfully manage their life cycles. With our fusion of medical, scientific and international regulatory experience, involving MD, PhD and Pharm D, we can develop solutions and strategies to answer your needs at every milestone and phase of product development. We can assist your Regulatory Affairs department through internally- or externally-based consultants, or offer a full Regulatory Affairs service platform at our offices.

Our Regulatory Affairs team can:

- Support the development of a regulatory submission strategy tailored to your product

- Compile, review and submit Clinical Trial Authorisation applications

- Liaise with Regulatory Authorities (NCAs, EMA) and Notified Bodies

- Write and review the compliance of M2 and M3; compile M4 and M5

- Prepare the CTD submission (NeeS) for MAA (national, DC, MR and centralised)

- Generate IMPDs and PIPs

- Assist Life Cycle Management (variations, line extensions, renewals)

- Advise on advertising and marketing practices, and legal requirements

Our areas of expertise include:

- “First to market” products