OSLO, Norway, May 03 2021 – LINK Medical, the Northern European clinical research organization (CRO), today announced the expansion of its regulatory team with the recent appointment of new regulatory directors in Norway, Sweden, and Denmark. This growth further builds upon the company’s existing capabilities in early development regulatory strategies including Investigational Medicinal Product Dossiers (IMPD), particularly focused on the Chemistry, Manufacturing, and Controls (CMC) section. The strengthened capabilities introduced by these new directors assist companies in achieving compliance with EU regulations that ensure clinical trial approval and patient safety.
The regulatory team offers strong expertise that supports customers within the early clinical development stages. This includes regulatory strategies, GAP analysis, IMPD, and CMC support, both for biologicals and non-biologicals, – The appointment of new regulatory directors enables LINK Medical to build an even stronger regulatory position in the Nordics, whilst also offering expertise that can cross borders and support customers globally. LINK Medical has one of the largest regulatory affairs team in the Nordics and today offers a stronger than the ever full-service regulatory team. Both large and small biotech/Medtech and pharmaceutical companies can get full regulatory support regardless of the development phase they are in.
Marianne Holst, Executive Vice President of Regulatory Services at LINK Medical, says: “We are thrilled to build upon our regulatory services with the addition of Lone, Hilde and Kristine to support our customers in the Nordics and beyond. This expansion of our in-house expertise, particularly in IMPD CMC regulatory affairs, illustrates LINK Medical’s dedication to the market success of our clients’ products.”
About LINK Medical
LINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe. We offer a well-integrated local presence in the Nordics, UK, and Germany. Reaching from early phase development to post-marketing, we have over 200 employees providing expert guidance across every aspect of a project – all from ONE source. Our promise is to improve and accelerate your product development through transformative methods, active communication, and optimal solutions. As a strategic partner, we provide expert competence and technology to enable evidence-based decision-making that supports the delivery of superior clinical outcomes.
For more information contact Marianne Holst
Marianne.Holst[@]linkmedical.eu
+4522158556
