Services
- Is your product a new chemical entity, advanced therapy or classified as an orphan drug?
- Is your target population rare or vulnerable?
- Do you need help requesting scientific advice from regulatory bodies?
Accovion can help you request and prepare for meetings with regulatory authorities and provide protocol assistance for orphan medicinal products. To facilitate timely patient access to your product, our experts can advise you on optimizing research and development, reducing uncertainties in regulatory outcomes and accelerating time to approval of your marketing authorization application.
Accovion can also help you identify and assess potential risks of your program. Our medical and statistical expertise supports your development risk management decisions across a variety of guidance papers, indication-specific considerations and regulatory policies.
Armed with a high level of competence, the best available and independent scientific knowledge, independence and total transparency, Accovion will stand by you and support your research.
Dr. Rainer Porrmann
Manager Study Coordination & Clinical Trial Submission
+49 6196 7709-385
