Our bio team has supported numerous (bio)pharmaceutical companies in developing and registering their biologics, biotechnology derived products, and vaccines.
Over the past years, the bio team supported several projects, including:
Preparation of briefing packages / scientific advice meetings with health authorities
Due-diligence and other, strategy and gap-assessments
Preparation and review of quality and non-clinical CTD sections for clinical trial applications and marketing applications
Preparation of post-approval applications such as variations, amendments and annual reports
Preparation of responses to questions from health authorities
Project management from early phase through marketing authorization
Act as consultant in internal multidisciplinary teams from our clients
The therapeutic areas we supported range from fertility to infectious disease and oncology. The drug types range from biotechnological products, recombinant proteins to vaccines (mRNA and recombinant vectored vaccines) and antibodies as well as antibody drug conjugates.
We focus on meeting your goals and due dates by an efficient execution of the projects.
Would you like to know how we can support you? We are happy to be in touch with you! Please use our contact form.
