LINK Medical helps Biotech and MedTech companies navigate through the regulatory framework. The LINK Medical Regulatory team is currently working on, among other things, the EU regulation 2019/6 on veterinary medicines.
For companies to succeed in taking their innovation from early development to product approval and launch in the commercial market, the regulatory topics need to be integrated throughout the process. LINK Medical has a regulatory team with over 50 employees in the Nordic region. They have extensive experience ranging from early development to regulatory activities after a medicinal product is approved and placed on the market.
– Regardless of the situation, we can help companies with almost any challenge and secure resources because of the large network of experts we have in all phases of product development and within the registration of medicinal products. says Kristine Nygren, Director Regulatory
There are many regulations that have been implemented very recently or are in the process of being implemented – which creates a challenge for many companies, Kristine Nygren says. On the other hand, it is new legislation to get acquainted with, and updates must be made because of this new legislation, which requires both time and knowledge.
– We must be well-read and updated regarding all relevant regulations. Our regulatory team has, for example, worked intensively with the EU regulation 2019/6 on veterinary medicines, she says.
The EU regulation was implemented on January 28 this year and came into force immediately. EU regulations are binding and must be applied in all EU countries in their entirety.
– We have worked extensively with this, and we have also recruited employees with experience from the implementation work from the authority. Now we are well prepared for the changes this regulation entails, says Kristine Nygren.
The new regulation was developed with the aim of stimulating innovation, reducing administrative burdens, and increasing the availability of medicines in the EU. It was also important to design directions that could help counteract the emergence of antimicrobial resistance and greater consideration for environmental impact.
Significant changes include, among other things, a new classification of variation applications that are now divided into variations that require assessment and those that do not. Variations that do not require assessment will be handled in the new product database, UPD. A new version of the QRD template for veterinary medicines has also been developed, which means that companies have five years to update their product texts.
Read more about the services LINK medical offers within Regulatory here
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 have one of the biggest Regulatory departments in the Nordics with highly specialized experts.
- LINK Medical has over 200 employees providing expert guidance across every aspect of a project – all from ONE source.
- LINK Medical has local regulatory specialists in all Nordic countries.
- LINK Medical handles over 6500 regulatory projects per year, ranging from single tasks to larger projects for small and big companies in all of Northern Europe.