Rx-to-OTC switches and the associated repositioning of pharmaceutical products from prescription (Rx) status to Over-The-Counter or OTC drug space represents an ever growing and huge commercial opportunity for pharmaceutical and life sciences companies.
Access to safe and effective non-prescription medicines remains a very critical and strategic objective. The opportunity to bring medications, technology, healthcare and life sciences professionals and patients together in an effort to bring overall synergies is still very wide open to be exploited for gaining market share and venturing into new and untouched territories.
A successful product strategy with an Rx-to-OTC conversion starts very early, at the project initiation stage and includes start-to-finish strategic drug development planning.
AXSource Consulting, with in-house experience in both full and partial Rx-to-OTC conversions can help you streamline the overall process.
AXSource Consulting offers a comprehensive package of Rx-to-OTC switch services that can be customized to meet specific client objectives. A few selected examples of our services are as follows:
Identification of key issues associated with prescription drug product (Rx) and assessment of Rx-to-OTC Switch Feasibility
We support and guide our clients to assess the risk adjusted probability of Rx-to-OTC switch regulatory approval, during the early evaluation stage. Services offered include:
Commercial Opportunity Assessment and Strategic Planning
We assess commercial viability of a potential Rx-to-OTC switch based on different market scenarios, competitive dynamics and external factors, and inform the best way forward to our clients. Services offered include:
Rx to OTC Switch Services, Process & Strategy
AXSource Consulting’s in-house expertise and technical consultants will closely work with you to define and outline a regulatory strategy and development program for your product. This includes the review of any related communication received from health authorities. The objectives will be met through cross-collaborative and iterative programs specifically designed to evaluate label comprehension, self-selection and actual use studies. Additional clinical studies may be required in certain cases; we can help design and conduct your clinical trials too.