Regulatory requirements for the development, manufacturing, marketing authorization and subsequent monitoring of biologics must be integrated within the complex biological and medical context. Consequently, it is critical to link scientific and regulatory knowledge at a very early stage in the development of biologics.
Our team includes biologists, biotechnologists, chemists, pharmacists, medical doctors and regulatory specialists. We have been supporting the development and regulatory affairs of new biological entities, biosimilars and Advanced Therapy Medicinal Products (ATMPs) for over ten years. If necessary our in-house team can be complemented by experienced experts within our network. Based upon your requirement we assemble a project team with the specific expertise to deliver an optimal solution tailored to the challenges of each complex biologic product.
Do you need an initial opinion on the regulatory science aspects of your project? Do you need support understanding the regulatory priorities needed to develop your lead molecule to the next level? Start with our Biologics Starter Package
For a detailed description of our services for biologics, see the corresponding section in Product Expertise.
Biologics - CMC - Regulatory / Biotechnologist
Phone: +49 7632/8226-591
Fax: +49 7632/8226-555