Regulatory affairs

Maintenance of marketing authorisations and product management

Do you need assistance handling your variations? Is eCTD causing you headaches? Do you know how long the submission procedure takes and what is the classification and cost of variations? Is anyone in your company monitoring legislative changes related to registrations and informing others about these changes? We serve as your expert guide to help you get through the jungle of regulatory requirements.

We offer the following regulatory affairs services:

  • Applying for new marketing authorisations and managing existing marketing authorisations throughout the Nordic and Baltic markets.
  • Managing all application types (CP, MRP, DCP, NP) and evaluating the content of your marketing authorisation documentation.
  • Coordinating common Nordic packages and managing the transfer of marketing authorisation holders.
  • Making submissions in accordance with the latest requirements (eCTD, NeeS, vNeeS).
  • Keeping your archives and product management up to date, and updating the electronic databases on your behalf.
  • Local contact toward authorities on your behalf.
  • We can draw up regulatory strategies that make it easier for you to get your products on the market.
  • The life cycle management of non-pharmaceutical products (e.g. food supplement notifications or preparing an in-house control plan) and review of packaging information and marketing claims to comply with official requirements and legislation.
  • Regulatory intelligence to keep you updated!

Translations

We offer expert medical translation services in all languages – fast and flexibly!

Training

We provide advanced training and mentoring for experienced regulatory experts, as well as orientation training for new experts for handling regulatory tasks.

Good regulatory practice

Are your regulatory processes in order? Does your organisation comply with Good Regulatory Practice?

Quality systems for regulatory processes ensure the consistent quality of your work, as well as cost-effective and uniform operating procedures.

Regulatory audits

Has your regulatory work ever been audited? We have strong expertise in regulatory audits, and we can help you evaluate your regulatory processes.