Regulatory services strategy

Regulatory

Regulatory
Marketing Compliance
Clinical Operations
Clinical Project Management
Medical Advice
Medical Writing
Data Management
Biostatistics
Safety & Pharmacovigilance
Market Access & RWE
Quality Assurance

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. MPD/IB/IND).
  • Compilation and submission of the Regulatory dossier.
  • CTA/IND application.
  • MA application.
  • Project Management.

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

Pre CE-marking

  • Classification of Medical Devices, In Vitro Diagnostics and Combinations of Devices and medicinal products.
  • Identification and application of relevant ISO standards, regulations, and guidance.
  • Formulation of Intended Purpose and medical claims, and how that can impact your regulatory strategy.
  • Workshops and in-house training for your regulatory pathway or Target Product Profile (TPP).
  • ISO 13485 QMS implementation, mock audits.
  • Development of GSPR checklist.
  • Gap analysis of Technical File, or of specific areas.
  • Technical File development, including Risk Management, Biocompatibility Plan, Usability Plan.
  • Development of Clinical and Performance Evaluation Plans and Reports.
  • Clinical Development Plan & study design.
  • Scientific Advice and Competent Authority contact.
  • Implementation of Unique Device Identification.
  • Development of Instructions for Use.

Medical Device

Post CE-marking

  • Post Marketing Surveillance (PMS).
  • EUDAMED filing.
  • Post-Marketing Clinical and Performance Follow up Study design and execution (PMCF/PMPF).
  • Translations to and from the Nordic languages and Readability testing.
  • Person Responsible for Regulatory Compliance (PRRC)

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