Regulatory Services - LINK Medical

Regulatory Affairs

A wealth of Regulatory expertise, at your service

We are one of the largest and strongest Regulatory teams in the Nordics with an all-inclusive approach – from discovery to commercialization. Our regulatory experts have worldwide experience in Regulatory Affairs from both the pharmaceutical industry as well as the Competent Authorities. We offer a Nordic approach, with a deep knowledge of the local regulations in the Nordics and in a variety of scientific disciplines. Our focus is patient safety – always. And we always delivery high quality- on target on time.

Contracts and Support

Outsourcing: We offer onsite/offsite local resources as well as direct access to global experts and we will customize our regulatory
services based on your unique needs and business challenges.

In house ad hoc support: Our regulatory ad hoc support is a flexible option that allows you to pay only for the tasks performed.

Projects: We also lead projects with a team of consultants that works for a client on a specific project.

Local Regulatory Support

Regional support in the Nordics.
Communicating with national competent authorities.
Professional translations to and from the Nordic languages.
We focus on linguistic and medical accuracy, readability, and patient safety as well as local regulatory compliance, such as QRD templates and Blue Box requirements.
Providing a Nordic review and regulatory assessment of multilingual Artwork.
Delivery of high-quality, scientifically accurate translations within a short timeframe and efficient translation projects with our customized SDL Trados Studio.
Maintenance of FASS & Felleskatalogen, and local databases (e.g. DKMAnet)

Pre-Marketing

Target Product Profile (TPP).
Regulatory gap analysis and review of regulatory documents.
Regulatory designations.
CMC support and documentation.
Pre-clinical support and documentation.
Scientific advice meeting.
Dossier writing (e.g. IMPD/IB/IND).
Compilation and submission of the Regulatory dossier.
CTA/IND application.
MA application.
Project Management.

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Post-Marketing

Maintenance of your Marketing Authorisation (variations, renewals, etc).
Update and translation of product information documents (SPC/LAB/PL) including proof-reading of labelling and artwork.
Translation of educational material.
Can act as your first contact to National Competent Authorities and Notified Bodies.
Consultation and advice on national legislation and specific requirements.
Risk Management Plans (RMP).
OTC Switch applications.
User Readability testing.

Medical Device / IVD

MD/IVD CE-marking & FDA Approval

Identify the regulatory strategy and the risk classification of Medical Devices, In Vitro Diagnostics and Combinations of Devices and medicinal products.
Identification and application of relevant ISO standards, regulations, and guidance.
The wording of the Intended Purpose and medical claims, and how these may impact your regulatory strategy.
ISO 13485/QMSR (FDA) QMS setup & implementation.
Gap analysis of regulatory strategy, Technical File, or other specific areas.
Technical File framework and development, including Design Control, Risk Management, Biocompatibility/Tox. Plan (BEP) & Report (BER).
Development of Clinical and Performance Evaluation Plans (CEP/PEP) and Reports (CER/PER).
Acting as the CRO including setup of Clinical Investigation Plan (CIP), study design and Clinical Investigation Report (CIR).
Scientific Advice and Competent Authority or Notified Body contact.
Support in EUDAMED and implementation of Unique Device Identification.
Performing Audits by experienced and certified Lead Auditors; Internal audit, supplier audit, CMO/CDMO audit, mock audit.

Medical Device / IVD

Post Marketing Surveillance

Lifecycle Management of Technical Documentation
Post Marketing Surveillance (PMS/PSUR).
Post-Marketing Clinical and Performance Follow up Study design and execution (PMCF/PMPF).
EUDAMED filing.
Translations to and from the Nordic languages and Readability testing.
Audits; Internal audit, supplier audit, CMO/CDMO audit, mock audit
Q/RA responsibilities and acting as a Person Responsible for Regulatory Compliance (PRRC)

Regulatory services strategy

Regulatory