Regulatory Affairs

 

 

Our Drug Regulatory Affairs team is ready to help and assist in all of the customer hurdles on the journey to regulatory approval.
We advise on the most effective regulatory approval strategy for each individual product – be it a generic medicine product, food or dietary supplement.
Our highly experienced employees:

•    Compile up-to-date application dossiers and registration documents according to the latest EU directives and guidelines following specifications such as eCTD (electronic Common Technical Document) or NeeS (Non-eCTD electronic Submission)
•    Plan and organize bioequivalence studies in collaboration with Contract Research Organizations (CROs)
Our regulatory services cover the entire regulatory lifecycle - from initial application to post-approval activities. We can manage registration procedures in the name of the client or register under our own name and transfer the resulting marketing authorizations afterwards.
•    Our regulatory experts are involved in the research & development phase from the outset, ensuring that the development and registration processes run quickly and cost efficiently so that our clients can get new products to market rapidly.