Regulatory Affairs


Do you need assistance in handling your variations? Is eCTD giving you a headache?

Do you know how long the submission procedure will take and are you familiar with the classification and cost of variations?  

 

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

Maintenance of marketing authorizations and product management

  • 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 authorization holders
  • Handling submissions in accordance with the latest requirements (eCTD, NeeS, vNeeS).
  • Keeping your archives and product management up to date as well as updating electronic databases on your behalf
  • 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 – quickly and flexibly!

Trainings

We provide advanced training and mentoring for accomplished 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 organization comply with Good Regulatory Practice?

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

Regulatory audits

Have your regulatory operations ever been audited?

We have strong expertise in regulatory audits, and we can help you evaluate your regulatory processes.

         

You may also be interested in the following services?

Food Supplements & Cosmetics Medical Devices Translations      

Contact us