Strategic Regulatory

Strategic Regulatory

Developing a product is only part of the task. Pre- and post-market support, health economics and product launch strategies are just as important. Our enterprising approach means that we will help you formulate a regulatory strategy that works to your advantage. And we don't stop with your product. Our teams are ready and waiting to support you as part of lifecycle management. Our teams are ready and waiting to support you through strategic regulatory consulting as part of our lifecycle management.

We ask the tough questions:

  • What are the right trials to conduct?
  • Is a certain activity really needed?
  • Is this the best approach for your product?

Our global experience provides us with the necessary local expertise to help you plan for market success. We understand the regional requirements related to your product launch and can support you in assessing additional potential revenue streams from marketing approval or via out-licensing.

Custom solutions we provide include:

  • Strategic regulatory consulting for product development and regulatory strategy for new therapeutics and combination products, including assessment of applicability of unique programs and pathways available for approval (e.g. breakthrough therapeutics, orphan drug status, eligibility for 505(b)(2)).
  • Patent extensions and market protection
  • Concept to commercialization strategies
  • In-license and out-license support
  • HEOR
  • Review and/or preparation of Investigational New Drug (IND), New Drug Application (NDA), Biological License Application (BLA), Abbreviated New Drug Applications (ANDA) and lifecycle management submissions, such as Post Approval Supplements (PAS), all with eCTD format
  • Assistance in clinical protocol design and clinical trial support (e.g. CRO selection and contracting, IRB selection, drug management/labelling) and advisory committee preparation
  • Assistance with regulatory agency meeting interactions, including preparing briefing documents, organizing meeting preparation sessions and leading FDA meetings. These include pre-IND, end-of-phase-2 (EOP2), pre-BLA, Type A, Type C and advisory committee meetings
  • Market analysis and forecasting
  • Competitive intelligence
  • Marketing survey development

Praise from our customers

Using Cmed's expert consulting team meant we were able to reduce our internal staff costs while having full access to true experts in order to accomplish our ambitious goals.

Want to learn more?

Please feel free to contact us if you would like to learn more about our skills and experience. We are friendly, open and here to help.

Contact us