Regulatory affairs

We’ll support you through the whole regulatory process

We have the regulatory expertise and experience within our specialized field of polymeric dosage forms and drug-device combinations products and can support and advise you on various regulatory matters during the development phase, in the registration process, and with post-approval changes. We can write, review, and compile the CMC documentation into a CTD structure with a strong focus on the device part of the product for EU and US applications.

Next to this, we can support you on CMC issues in formal Health Authority meetings and respond to deficiency letters in collaboration with your regulatory team. Having experience in different research and development settings and being accustomed to interacting with the operational side and the combination thereof makes us a valuable partner for your ambition to bring your idea to the market.