For Biotech and MedTech companies to succeed in taking their innovation from early development to product approval and launch in the commercial market, regulatory expertise needs to be integrated throughout the process. With the goal of supporting more Swedish companies to comply and understand the complex regulations during the whole process, the CRO company LINK Medical is now expanding its regulatory department with a greater team in Uppsala, complementing the existing teams in Stockholm and Malmö.
Nordic co-operation – a recipe for success
– Uppsala is a thriving life science area with many small biotech companies, and therefore, it was important to increase our presence with a regulatory team here. Implementing this initiative in the middle of the pandemic and continuing to support our existing customers with the same high quality has been possible thanks to our broad expertise, Kristine Nygren, Director Regulatory, says and continues:
– We have a regulatory team with over 50 employees in the Nordic region, with experience that extends from early development to regulatory activities after a product has been approved and placed on the market. It is our expertise and our vast network within LINK Medical with experts in all phases of product development and registration of medicinal products, that allows us to secure resources, regardless of the situation.
Contributing with advice from start to finish
The regulatory department in Sweden gathers senior competence in product information and regulatory expertise from the pharmaceutical industry and the Swedish Medical Products Agency. This includes expertise in regulatory CMC and within the medical device field, as well as related areas such as quality assurance, GDP, and drug safety.
– Our broad expertise makes it possible to adapt to different customers’ needs, states Kristine Nygren.
“Risk of never reaching the market”
The risk of not working actively with regulatory experts during the planning and the entire process could result in unnecessary delays which turn into additional costs, says Kristine Nygren.
The end result is that in many cases, is that products never reach the market. By using a full-service regulatory team, the company can both succeed faster and save money, she says.