• Are you in need of regulatory affairs translations that meet strict industry standards and are systematically completed within the health authority´s strict agenda?

Novalins is a leading provider of regulatory affairs, PV, and safety translations. With over 3000 medical experts including a dedicated group of 1800 EU-based pharma collaborators combining regulatory knowledge and translation expertise, we continually deliver exceptional results for our clients.

Our services are for you if you’re looking for a certified provider (ISO 9001-2015 Management, ISO 17100:2015 Translation Services and ISO 13485:2016 Medical Devices) who:

  • Can handle all type of regulatory documents and procedures (CP, DCP/MRP, NP).
  • Has the capacity to cover all languages for regulatory submissions in America, Europe, China and Japan.

Can guarantee that all of your documents will be accepted by international and local health authorities.

Work with a Partner Who Understands the Regulatory Industry

We understand the regulatory requirements like few other translation providers.

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.

Hetero Labs has relied on Novalins for SmPC and PIL labelling translation into multiple EU, Asian and African languages. We have been very satisfied with the quality of their work and their ability to make strict deadlines. Their translations are accurate and follow industry standards and authority requirements, which has consistently resulted in regulatory approval of our submissions.

Hetero Labs Limited

Gain Access to Unrivaled Skills and Expertise

Any time you’re dealing with regulatory affairs, PV and safety translations, you need a provider that has the ability to meet the numerous requirements set out by the industry.

When you partner with us, you’ll be working with experienced project managers and a strong network of medical translators who specialize in regulatory translations. Our team is extremely familiar with the requirements set by the EMA (such as QRD formats, EDQM termbase, and medDRA) and the requirements of national 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.

We have been working with Novalins since 2011 on pharma-regulatory translation projects (mainly SmPC, PIL, Labelling) in all EU languages and is very satisfied with the level of work they systematically provide. They have extensive experience when it comes to regulatory documentation, EMA/national health authorities´ requirements, and the translations they provide have always been delivered on time and eventually approved by regulatory bodies.

Alkaloid AD Skopje

Get Your Regulatory Translation Projects Done Right

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.

Torrent Pharma has collaborated with Novalins for the translation of our product monographs to meet language requirements of Health Canada. The service is always executed quickly, according to our standards, and in compliance with Canadian health authorities´ requirements. Communication with Novalins is timely and professional.

Torrent Pharma

Get a Free Quote or Sample for Your Project Today

Are you ready to get started? Fill out the form below to receive your free regulatory translation quote or a free translation sample and one of our team members will be in touch with you shortly.

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