Strategic advice is where we begin.  In a Regulated environment, getting the decisions right about where you are and how you will get to where you want to get to in the best, most efficient, and most likely successful manner are crucial.  Having a well thought out, well understood development plan will help ensure that you can get to market and be successful at the earliest opportunity.  Our approach is to form a strategy that will clearly define the end goal, considering all product attributes and agency requirements of where you (eventually) want to get to.  A few examples (but not exhaustive) include:

  1. License Due diligence - our range of expertise in understanding not only the technical but also the commercial aspects of reviewing existing licenses that you may wish to commercialize is significant.
  2. Detailed gap analysis/Regulatory intelligence/Competitor Monitoring
  3. Regulatory Guideline Deficiency Analysis - ensuring the product is meets all regulatory guidelines throughout development process.

It is also equally important to get the correct scientific advice for regulatory and HTA requirements at the earliest opportunity in the development cycle to minimize risk and maximize successful submissions.  We can assist in creating the strategy and then planning on its execution over a period of months or years, depending on where we are working with you in the Life Cycle of the development.