Regulatory Affairs

On schedule in 26 EU languages

background image

Translations of medicinal product authorizations

to a perfect quality standard

When it comes to regulatory affairs translations, you need a company that can ensure compliance with your deadlines in addition to delivering a flawless translation compliant with regulatory specifications. All of your documents need to be translated into up to 25 languages without delay and to high quality standards by a reliable language service provider. There is no way around this when it comes to submitting your authorization documents.

The right contact partner for every type of medicinal product

We are the right language service provider for all your translation needs and every type of medicinal product – whether generics, orphan drugs or biosimilars. mt-g specializes in accurate translations in the field of regulatory affairs and is well acquainted with all relevant authorization procedures, be they national, centralized or decentralized.

Almost 25 years of experience in the authorization process

In order to quickly bring you one step closer to receiving authorization for your medicinal products, we can provide you with specialized translations that comply with all regulatory requirements and guidelines. In fact, this is what we have been doing for almost 25 years.

Reliable translations

for regulatory affairs

We translate all documents required for authorization of your medicinal products by the stated deadlines and to the highest quality standards. Your translations are guaranteed to comply with the current QRD templates as well as all associated appendices, MedDRA terminology, and EDQM Standard Terms.

  • QRD templates, including appendices
  • Templates of the national regulatory authorities
  • EDQM Standard Terms
  • Excipients annex
  • Annex A, Annex IV, Article 127a
  • Table of non-standard abbreviations
  • Names of EU-EEA countries
  • Excipients guideline
  • Compilation of QRD decisions on stylistic matters in product information
  • Abbreviation of names of days on calendarized blisters
  • QRD convention
  • EMA PDF user guide and checklist
  • Documentation on drug safety (pharmacovigilance)
  • eCTD components (modules 1–5)
  • GMP-relevant documents
  • SOPs
  • Correspondence related to the authorization process
  • Centralized procedure (CP), including accelerated procedure
  • Decentralized procedure (DCP)
  • Mutual recognition procedure (MRP)
  • National procedure (NP)
  • Variations
  • Line extensions
  • Renewals
  • Workshare
  • Urgent safety restrictions
  • Article 61 (3) notifications (Label/PIL)
  • Referral procedures
  • Creation of patient-friendly package leaflets, including readability studies and bridging
  • Pre-opinion and post-opinion support
  • Creation of PDF files in accordance with the guideline and checklist
  • Support during linguistic review
  • Quality assurance during the translation process within regulatory compliance
  • Software-assisted quality checks

mt-g is your reliable partner

for regulatory affairs ...


  • translating your authorization documents into up to 26 languages,
  • meeting the extremely short deadlines for medicinal product authorization despite the large number of texts to be translated,
  • offering maximum flexibility in meeting deadlines after receipt of a positive opinion, even on weekends,
  • demonstrating the highest level of expertise in order to ensure that the authorization dossier is submitted on time, and
  • always keeping an eye on your budget.

A forward-looking
language service provider

for translations in the field of regulatory affairs

We speak
your language
  • mt-g translates your regulatory affairs documents into all European languages.
  • Your project manager is your personal point of contact. They will advise you on all project-related issues and guide you through the entire translation process.
Careful planning
for accurate translations
  • We guarantee the timely delivery of national-language documents through the careful planning of every translation process.
  • mt-g guarantees straightforward and direct communication thanks to the rapid response times of our project managers.
Always there
for you

We know how important the period between the positive opinion and authorization is for you and your medicinal product. In order to ensure that you can submit your national-language authorization documents on time, we will be there for you after you receive the positive opinion – including at weekends.

creates trust
  • Our project management team specializes in regulatory affairs and is well acquainted with all regulatory requirements and QRD templates.
  • Our translation agency is certified according to the exacting requirements of the international ISO 9001 standard.
  • If required, we can also translate your regulatory affairs documents in accordance with ISO 17100. Additional steps in the standard driven translation process further raise the quality through even higher requirements in terms of qualification and expertise.
Transparent language service

With our clear and transparent quotes, there will never be any hidden cost for your regulatory affairs translations.

Simple & direct

mt-g is known for its personalized and friendly work approach.

We always match our services to precisely meet the specifications of our customers from the medical and pharmaceutical sector. The project managers in the Regulatory Affairs team will guide you through every step of the translation process.

Our designated international translators know each customer’s requirements very well. This guarantees that the regulatory affairs translation we deliver to you matches to the original.

We welcome the opportunity to complete a sample translation. This will give you a chance to see for yourself the quality of our translations in the field of regulatory affairs.

With your project manager, you will agree on:

  • All translation details for COVID-19-specific texts and documents
  • A detailed project timeline and all deadlines for submitting your authorization documents
  • Any specific textual features of your authorization documents
  • Milestones during the ongoing process


Translation of your authorization documents for Switzerland

We can translate your authorization documents, which will mainly be in German, into French and Italian and, if required, also into English for submission to the Swiss regulatory authority SWISSMEDIC. Naturally, we will take all the relevant regulatory requirements into account.

We know what is important: Our project managers and specialized translators are deeply familiar with the differences compared to the EU authorization process as well as with the special linguistic considerations of Switzerland.

Authorization and medicinal product-specific documents
(especially for the Swiss medicinal product authorization process)

  • Swissmedic Information for healthcare professionals and Patient Information
  • Documentation on drug safety (pharmacovigilance)
  • Correspondence related to the authorization process
You can learn more about how personal data is used in our Privacy Policy.