LINK provides regulatory services related to human and veterinary medicinal products (including medicinal gases and herbal medicinal products), food supplements, cosmetic products and medical devices.
Between them, our Regulatory affairs Associates have amassed several decades of experience from both the pharmaceutical industry and the competent authorities. Our regulatory services vary from small tasks such as simple variations, renewals and translations, to larger projects such as compiling of dossiers and regulatory strategies:
- Regulatory strategy
- Applications for Marketing Authorisations
- Maintenance of Marketing Authorisations
- Catalogue texts
- Translations
- Pharmacovigilance
- Outsourceable resources - regulatory affairs associates, safety officers
When providing regulatory services, we work either from our own offices or on our customers’ premises, depending on our customers’ needs. We can also serve as an external Scandinavian regulatory department for small organisations or organisations without a national regulatory department.
As a Scandinavian CRO (Clinical Research Organisation) with offices in Oslo, Stockholm and Copenhagen we provide you with local expertise.