Regulatory Affairs

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?  We serve as your expert guide to help you get through the jungle of regulatory requirements.

Maintenance of marketing authorizations and product management

We offer the following regulatory affairs services:

  • Applying for new marketing authorizations and managing existing marketing authorizations throughout the Nordic and Baltic markets
  • Managing all application types (CP, MRP, DCP, NP) and evaluating the content of your marketing authorization documentation
  • Coordinating common Nordic packages and managing the transfer of marketing authorisation to new holder
  • 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
  • Regulatory intelligence to keep you updated!
  • 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 support for medical devices

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.

Contact us