Switching prescription products to OTC can be a complex yet rewarding option for pharma companies. Many factors need to be taken into consideration, includingNational and Regional regulatory environment, Clinical feasibility of OTC switch, potential for misuse, therapeutic positioning, current competitor products and distribution models. Getting it right provides an opportunity to reinvigorate a brand and generate ongoing revenue streams for, in particular, end of patent products. There are many opportunities and barriers to its success and getting good advice up front can save immense time, money and ultimately the chance of the OTC switch being a success.
NDA has a dedicated OTC Switch team consisting of experienced Clinical, Regulatory and Pharmacovigilance professionals, who can provide a consolidated OTC feasibility assessment and Regulatory strategy for your markets of interest. Our team of experts ensures that the prospective switch is assessed from multiple perspectives, increasing its chance of acceptance and success on the market. The OTC Switch Team can also work with NDA’s unique Advisory Boards to corroborate the proposed OTC strategy.
Our track record
The NDA Switch team has experience of working on over 60 switch assessments or switch applications to global agencies for multi-national drug companies.
How we help
NDA Group can support you with any OTC Switch requirement, including a detailed OTC feasibility assessment, support for Agency meetings right through to an OTC MAA. We can help with feasibility planning in target markets and conduct a thorough review of the ‘OTC’ ability of individual molecules from a clinical and regulatory perspective, in various therapeutic areas. Our team, based in office in the US, Germany, Sweden, Switzerland, and the UK, coupled with our established links with national regulatory consultancies in other EU and US territories, provide national input and advice along the way, it is this national perspective which can be critical for OTC switches.