Granconsult

Document Development

One of the services our company provides is document development. Our specialists have extensive experience in creating medical-domain documentation. This allows us to guarantee that our clients receive materials of the highest quality. You can also be sure that the documentation we produce will comply with all medical standards (Russian Ministry of Health, FDA, EMEA, etc.).

Our specialists can develop documentation required for any type of study (preclinical, clinical or other) and can also analyze documents the client already has.

Granconsult offers the writing and preparation of the following documents:

  • Drug development plan
  • Registration dossier
  • Regulatory document
  • Pharmaceutical section of the registration dossier
  • Registration applications
  • Clinical development plan for the drug
  • Protocols
  • Case Report Forms
  • Investigator’s brochure
  • Informed consent
  • Clinical study report
  • Clinical section of the registration dossier
  • Abstracts, journal articles
  • Drug safety report
  • Preclinical report, overview
  • Scientific and/or medical overview

We work with every client individually so that the client can be confident in the quality of the service and in the reliability of the resulting information.

Translation of documentation related to the medical field is rightly considered specific and highly specialized. In addition to the fact that translating medical documents requires specialized knowledge, it also demands a high level of responsibility — human life can depend on the accuracy and correctness of a medical translation.

Demand for medical translation is steadily growing. One reason is the increasing number of foreign drugs entering the Russian market.

Translation is also required for various research results (clinical, bioequivalence, etc.) performed by foreign researchers.

Our specialists perform foreign-medical translations of any complexity — from medical-equipment user manuals to foreign medical dissertations.

Many clients turn to us for specialized translations when consultation at an overseas clinic is needed. In such cases it is vital to translate the diagnosis, medical history, test results and many other documents with maximum accuracy, fidelity and linguistic sensitivity.

By choosing our company for translation services, you can be confident that your diagnosis will be interpreted correctly abroad and that no problems or misunderstandings will arise.

Please note that medical translations are carried out by narrowly specialized experts — after all, a dermatologist could hardly make a competent diagnosis concerning the heart or internal organs. The same goes for translation: the person performing a medical translation must be competent in the specific field.

Such specialists work in our company. We are committed to continuously developing and improving their knowledge, which gives us confidence in the quality of our translation services.

Our company works with various types of documents, including:

— medical case histories, personal outpatient cards;

— results of various studies (clinical, preclinical, bioequivalence);

— documentation required for drug registration;

— medical-equipment technical passports;

— other medical-domain documents.

An advantage of working with our company is our fast turnaround and the confidentiality of the personal information submitted for translation.