Strategic Regulatory Consulting

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.

 

We ask the tough questions:

>  What are the right trials to conduct?
>  Is a certain activity really needed?
>  Is this this 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:

>  Regulatory consultation 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.”