Biologicals

Thanks to our extensive experience working with Biological products and Biosimilars, we are the ideal partner for defining the best regulatory strategy for our clients´ Biological products.

As part of our modular and flexible support model, we can either assist you with gap analyses of existing documentation or take on the preparation of entire registration dossiers.

We can advise on critical interactions with authorities, such as scientific advice procedures, and can manage them completely for our clients.

Difficult topics, like the extrapolation of indications, are assessed and managed by our senior experts.

We have successfully written full biosimilar dossiers, including all CMC parts, non-clinical and clinical sections, have prepared and attended pre-submission meetings with EMA, and have supported the management of Centralised Procedures and Biologics License Applications, including elaboration of responses to authorities.