Drug authorization

Adherence to deadlines for 24 EU languages

Translations of medicinal product authorizations

to a perfect quality standard


When looking for a partner to assist you with your drug authorization procedure, you need a company that can ensure compliance with your deadlines in addition to delivering a flawless translation. All of your documents must be translated into up to 24 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 point of contact for every type of medicinal product

We are the right language service provider for all of your translation needs when it comes to every type of drug, whether generics, orphan drugs, or biosimilars. mt-g specializes in precise translations in the area of drug authorization, and it is well acquainted with all relevant authorization procedures, whether national, centralized, or decentralized.

More than 20 years of experience in the drug authorization process

In order to bring you quickly one step closer towards receiving authorization for your drugs, 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 more than 20 years.

Reliable translations

For drug authorization

 

We translate all of the documents that are necessary to receive authorization for your drugs 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 applicable appendices, MedDRA terminology, and EDQM Standard Terms.

  • QRD templates, including appendices
  • Templates of the national authorization agencies
  • EDQM Standard Terms
  • Excipients annex
  • Annex A, Annex IV, and 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 calendarised blisters
  • QRD convention
  • EMA User guide on how to generate PDF versions of the product information, and EMA 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 assessment
  • Decentralized procedure (DCP)
  • Mutual recognition procedure (MRP)
  • National procedure (NP)
  • Variations
  • Line extensions
  • Renewals
  • Workshare
  • Urgent safety restrictions
  • Annual re-assessments
  • Article 61 (3) notifications (Label/PIL)
  • Referral procedures
  • Creation of patient-friendly package leaflets, including readability studies or bridging
  • Pre- and post-opinion support
  • Creation of PDF files in accordance with the guideline and checklist
  • Support during linguistic reviews
  • Regulation-compliant quality assurance during the translation process
  • Software-assisted quality checks

mt-g is your reliable partner

For drug authorization procedures that ...

  

  • translates your authorization documents into up to 24 languages,
  • meets the extremely short deadlines for drug authorization despite the large number of texts to be translated,
  • offers maximum flexibility in meeting deadlines after receipt of a positive opinion, including even on weekends,
  • exhibits the highest level of expertise in order to ensure that the authorization dossier is submitted on time, and
  • always keeps an eye on your budget.

A forward-looking
language service provider

For translations in the area of drug authorization

We speak
your language
  • mt-g translates your authorization 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 precise 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 due to the rapid response times of our project managers.
Always there
for you

We know how important the period between the receipt of the positive opinion and the authorization is for you and your drug. 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 on the weekend.

Specialization
creates trust
  • Our project management team that specializes in drug authorization is well acquainted with all regulatory requirements and QRD templates.
  • We are a translation service provider that is certified in accordance with the high standard of the international ISO 9001 accreditation.
  • If you prefer, our certified Team 17.1 can also translate documents for your drug authorization in accordance with ISO 17100. Additional steps in the translation process increase quality still further through the application of even higher qualification and professional competence requirements.
Transparent
language service

Thanks to our clear and transparent quotations, there will never be any hidden costs for translations for your drug authorization needs.

Simple & direct

mt-g stands for a personalized and accommodating way of working.

We adapt our services to precisely meet the specifications of our clients from the medical and pharmaceutical sector. In addition, our international regular translators keep constantly up-to-date about all customer requirements. This guarantees that the medical device translation that we deliver to you is faithful to the original. The project managers who are dedicated to this area will personally guide you through every step of the translation process.

We would be pleased to provide you with a test translation. This will give you a chance to see for yourself the quality of our translations in the area of drug authorization.

You will be able to clarify the following with your project manager:

  • sämtliche Übersetzungsdetails zu Covid-19 spezifischen Texten und Dokumenten
  • 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

Swissmedic

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 authorization agency SWISSMEDIC. Of course, we will take all the relevant regulatory requirements into account.

We know what is important: Our project managers and specialist translators are very familiar with the differences from the EU authorization process as well as with the special linguistic considerations of Switzerland.
 

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

  • Swissmedic Information for healthcare professionals and Patient Information
  • Documentation on drug safety (pharmacovigilance)
  • Correspondence related to the authorization process
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