RegSmart Life Science has signed an agreement with Aleap, the incubator hub for health startups in Oslo, Norway. The purpose is to support the innovative early-stage community companies with regulatory advice when developing pharma and medical device products.
”We are excited to partner with Aleap and support their member companies to navigate the complex regulatory environment.”, says Agneta Larhed, senior consultant at RegSmart. ”While we are a relatively young consultancy, our extensive industry experience is critical for early-stage companies. Investors are consciously aware of the highly regulated health industry, so it is imperative that startups can present their regulatory milestones with credibility and confidence.”
”Developing innovative health solutions means that you also need to navigate your way through complex regulatory environments”, states Aleap’s head of service provider program, Mariann Dønnum. ”If you haven’t mapped out what your regulatory journey looks like then your entire business is at risk”. With this in mind, Aleap has enhanced its portfolio of service providers with the addition of regulatory consultants, RegSmart.
“With their long regulatory experience from senior positions at regulatory agencies and from small and big life science companies, RegSmart can facilitate regulatory strategy development by adding ”what to do, when, and how”. They can provide expert advice and support in relation to European and US regulatory requirements, and help develop a regulatory plan as part of an overall project strategy,” concludes Mariann Dønnum.
RegSmart will be in the Aleap incubator each month for consultations with Aleap members, starting January 2023.
Aleap, a non-profit incubator, has created a community for health startups in Oslo, Norway. The mission is to facilitate innovation and value creation by developing an ecosystem for health startups that allow ambitious entrepreneurs and companies to create new products better and faster. They do this by offering a broad range of critical know-how expertise, flexible infrastructure and international business networks. They believe that entrepreneurship and successful startups will benefit from collaboration in a multidisciplinary environment where sharing with others is fundamental.