Regulatory Affairs

Over our many years in business, we’ve translated a wide range of regulatory documents, including:

• Marketing Authorisation Dossiers 
• CTD modules
• Summary of Product Characteristics (SmPC)
• Patient Information Leaflet (PIL)
• Packaging and Labelling
• Validation protocols
• Expert reports
• Instructions for Use
• Risk management
• Periodic safety reports

To date, Novalins has successfully translated thousands of QRD-compliant documents in all EU languages for a number of different drug approval procedures in the frame of Centralized Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), Referral Procedure, and Type IA/IB and Type II Variations.

By working with us, you’ll gain access to a wealth of experience when it comes to translating product information for human and veterinary medicinal products that meet the requirements of both the EMA and national health authorities.

We select our medical translators extremely carefully to ensure the quality of our work remains high. Not only do all of our translators have a scientific background, but we’re proud to include in our team:

• 600 medical doctors and 900 PhDs who specialize in a broad range of therapeutic areas.
• 400 professionals with regulatory experience in the Pharma and Medical Devices industries.
• 70 former agency reviewers and inspectors from EU countries, the United States, Canada, Brazil, and India.

This strong expertise is backed up by our three ISO certifications and our 10-year experience, so you always have peace of mind that your medical translation projects are in capable hands.

When you work with us you’ll enjoy:

• Proprietary Clients’ Portal: This free service allows you to centralize your activity and easily collaborate with your team members. You’ll be able to add users to the portal, exchange files and messages on our messaging system (without the use of email), and have instant access to all of your project information. 
• A Reliable Partner Who Understands Your Industry: Team up with a partner who specializes in the healthcare sector and has extensive knowledge of the specific requirements inherent to the regulatory world.
• Quick Turnaround Times: Benefit from our large network of translators and sophisticated tools that allow us to deliver accurate multilingual translations quickly and efficiently. 

Certificates of Accuracy: After each project is complete you’ll receive a certificate of accuracy that includes our unique methodology and the background of all the team members assigned to your specific project. These certificates are recognized by most regulatory bodies.