Zenith can support you develop a strategy for your NDS and sNDS.
Our expertise spans from innovator product in niche therapy areas such as rare diseases, oncology, gene therapy, all the way to generics and mainstream treatments.
We are deep expertise in medical device approval submissions and combination products.
Regulatory strategy, license applications, post-marketing life cycle, reimbursement and Market Access consulting
Agency Meetings management, Pre-ITA, Pre-Submission Appeal and Q meetings
Risk Assessments: Evaluating new product risk risks in processes, products, and suppliers.
Risk Mitigation: Implementing strategies to mitigate identified risks.
Application dossier compilation
Product Classification, Request for Designation
Clinical Trial Application Guidance and Submissions (ITA and IDE)