Regulatory Strategy & Evaluation

At consult2deliver we see legislation as an opportunity to work creatively within the available regulations, to deliver real commercial success.  We use robust scientific methodology to gather evidence (literature, in house data) to justify our approach. We are comfortable working with the unknown, to provide our clients with an answer.

Regulatory Strategy

Successful delivery of a development programme, requires a well defined regulatory strategy to identify barriers and gaps.

consult2deliver can provide solutions for

  • Where does my idea/product fit? (with outline scenarios)
    • What is the best route to market?
    • How to optimise SME status, where applicable?
  • Short/long term strategies
    • Do you want to launch a product through all stages of development?
    • Achieve Clinical Trial approval
    • Attract further investment?
  • Supporting an innovative concept to attract grant funding
    • Assistance in writing/reviewing healthcare and biosciences grants

      Innovation in these two sectors is supported through central grants via the Technology Strategory Board (TSB).

      The TSB run several grant competitions and awards every year. These are published and maintained on their web site.

      Through our expertise in writing and gaining awards consult2deliver can assist with:

      • writing and reviewing TSB grant applications
      • bibliographic reviews to support grant applications
      • identify competitions that may be applicable
  • Project Management to deliver regulatory milestones (etc)
    • Scientific advice
    • Clinical trial applications
    • Dossier submission

Regulatory Evaluation

For projects with an established regulatory strategy it may be helpful to have an independent/external

  • Review of current regulatory strategy, impact of transitional legislation or impending changes.
  • Perform gap analysis on dossiers or programme
  • Evaluate & review
    • CMC /Module 3
    • Non Clinical/Module 4
    • Clinical/Module 5
    • Active Substance Master Files

consult2deliver can assistance in providing these services to validate completeness of a dossier/data for due diligence or milestone reviews.