Partners

The occasion of the VCoE Members' Meeting

The Venture Centre of Excellence, a public-private co-investment programme of EIT Health and the European investment Fund (EIF) to empower finance for European health small and medium size enterprises (SMEs), has announced on the occasion of the VCoE Members' Meeting

plg
Healthcare
Corporate

The Venture Centre of Excellence, a public-private co-investment programme of EIT Health and the European investment Fund (EIF) to empower finance for European health small and medium size enterprises (SMEs), has announced on the occasion of the VCoE Members' Meeting, taking place alongside the Bits & Pretzels Healthtech event in Munich on June 29, 2022, a strategic and exclusive partnership with ProductLife Group (PLG), a life sciences consulting company expert in regulatory strategy and compliance at all stages of the product lifecycle. 
The goal is to strengthen the regulatory and compliance support to innovative life sciences start-ups, so that they benefit from a smoother and faster go-to-market of their products. 

Indeed, innovative start-ups entering the Life Sciences market have to know that, whether they are in pharmaceuticals, Biotech or MedTech area, they will have to anticipate and comply all along their road for innovation with strong, detailed, multiple and evolving regulations. Both complexity and evolving nature of regulations may indeed significantly impact. This is why regulation is mostly seen as a barrier to innovation as a large number of start-ups experience regulatory difficulties. It requires specific and up-to-date knowledge and skills and is very often the second cause of failure after funding issues.

Thanks to our strategic partnership, we will contribute to reduce risks for VCoE investors and increase start-ups’ chance of success:

  • First, PLG will support VCoE members in start-ups assessment and selection, participating in gap analysis when needed and relevant, and contributing to enrich deck teasers for fundraising. The idea is not to select already fully compliant start-ups, but to secure risk management, taking into account the maturity stage, current quality practices and skills. This should support and secure investment strategy.
  • Then, PLG can support start-ups in implementing at the earliest stage of their product development a quality management system (QMS), that will evolve with ever-changing ang more stringent regulations as they go through maturity stages. Such a quality by design philosophy should both increase compliance and reduce global costs. 
  • In addition, regulatory and compliance is not a “silo” per se but gathers multidisciplinary efforts from all other dimensions involved in developing the innovation (science, technology, clinics, medico-economics, business models…). Achieving stringent timelines assumes a fluid and efficient coordination. PLG can bring experts in complex life science project management including strong regulatory affairs skills and risk management to support the start-up team and secure investors deadlines and start-ups use of profits.

Beyond the “barrier” vision of regulatory and compliance, we believe that regulatory and compliance should be a strategic pillar for innovation to leverage value for the start-up and her ecosystem. Regulatory and compliance aspects can make the difference in selecting markets and their ROI - associated clinical development plans, pricing and market access.

For more information, contact PLG fgalzin@productlife-group.com