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More about Regulatory affairs

Our regulatory affairs service at LINK Medical provides you with the experience, ability and integrity to support development of medicinal products and medical devices. These regulatory services vary from small tasks completed within a couple of hours to larger projects lasting several months or years. When providing regulatory services, we can work from our local offices, as well as from the customer’s own premises. We can serve as the local regulatory department for small organisations or organisations without a national regulatory department in the Nordic or Baltic region.

Regulatory Strategies

Our senior regulatory associates are experienced in drug development and validation of regulatory documents. They can advise you through the drug development phase, from product concept to submission of the marketing authorisation application.

Our services include:
  • Regulatory advisory services
  • Assessment of suitability of available documentation, e.g. chemistry, manufacturing and control (CMC) documents, pre-clinical data and clinical data in terms of quality and compliance with guidelines
  • Choosing the most appropriate application procedure (centralised, mutual recognition, decentralized or national) as well as the type of application (e.g. complete, bibliographic, generic, hybrid or traditional use)
  • Establishing product development plans for the pharmaceutical development phase, the pre-clinical phase and/or the clinical phase
  • Preparation of pre-submission meetings and scientific advice/protocol assistance
  • Rx-to-OTC switch strategies

Preparation of dossiers

LINK Medical assists in the preparation, assembling, validation and submission of your application dossier.

We will help you to compile the regulatory documents required for your dossier (such as MAA, NDA and IMPD), as required in the relevant regulations. Our regulatory associates are experienced and know exactly how to prepare the documents for your dossier.
These include:

  • Chemistry, manufacturing and control (CMC) documents, including quality overall summaries (QOS)
  • Pre-clinical overviews and summaries
  • Clinical overviews and summaries
  • Product information texts, including summary of product characteristics, package leaflets and label texts
  • User/readability testing of package leaflets

LINK Medical can communicate with the authorities on your behalf during the application procedure and assist with the responses to assessment reports.

Post approval support/maintenance work

LINK Medical takes care of all the steps involved in maintaining marketing authorisations, for example:

  • Variations
  • Transfer of marketing authorisations
  • Renewals
  • Periodic safety update reports (PSURs)
  • Updating summary of product characteristics (SPCs), label texts and package leaflets
  • Proof-reading of labels and leaflets
  • Catalogue texts, such as Felleskatalogen or FASS
 

Translations

Our regulatory associates have experience from a variety of therapeutic disciplines and can easily consult experts within the different areas. We focus on linguistic accuracy, as well as compliance with mandatory templates, such as quality review of documents (QRD) templates.
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