We translate the following documents for major global pharmaceutical companies and CROs:
- Registration dossiers, marketing authorisation applications (MAA);
- Preclinical and clinical trial materials;
- Bioequivalence study reports, pharmacovigilance reports, GMP inspection reports;
- GMP certificates and CPPs;
- Manufacturing licences, SmPC, PIL, CCDS, PSUR, PBRER, RMP;
- Quality control methods for medicinal products (QCM MP);
- Certificates of analysis (COA), certificates of quality (COQ), certificates of release, etc.
We have translated 320,000 pages of medical translation for such companies as:
We translate the following documents for the manufacturers and importers of medical devices: operation manuals and instructions for use of medical devices, catalogues, brochures. We provide desktop publishing services (DTP) for recreating any charts and images with an embedded text.
Our clients are thus provided with the fully translated and formatted print-ready materials that need no further revision. We cooperate with medical centres and translate materials in other areas: cosmetology, chemistry, biology, zoology, cytology, genetics, etc.
Profpereklad works with corporate clients only. We do not translate personal medical certificates or patient records for private clients. We estimate that we have worked with every third pharmaceutical company operating in Ukraine.
Terms of translation
We will translate a 100-page Periodic Safety Update Report (PSUR) in 8 days, but we can do it faster if the deadline is too short
Why Should You Choose Us?
Having medical translation be performed by translators who are not medical experts is very risky as a mistake may result in a life lost.
- Your project will be handled by qualified specialists―the vetted translators with a degree in medicine/pharmacy or an industry-specific experience of at least five years, who are up-to-date in terms of the medical and pharmaceutical translation.
- Each medical translation goes through several rounds of proofreading: the post-translation round of proofreading by the translator himself or herself, the reviewer’s revision of any inaccuracies and mistranslations, and the final proofreading by the in-house proofreader for any typing errors―all in accordance with the international standards EN 15038 and ISO 17100. Any inaccuracies, grammar or punctuation mistakes will be corrected.
- We understand how important it is to maintain consistency in the medical terminology. Abbreviations, industry-specific terms, and established concepts are translated in accordance with the client’s glossary as well as industry-related standards and regulations.
- Moreover, we apply advanced IT solutions, namely, the translation memory technology (not to be confused with machine translation), thanks to which we are able to ensure accurate and consistent terminology used in all of the client’s projects.
- Our team of medical and pharmaceutical project managers will make sure that we provide accurate and timely services, and in strict compliance with the client’s preferences.
790 clients are satisfied with our medical translation
In particular, numerous translations of certificates of GMP compliance of a manufacturer, manufacturing licenses (ML), powers of attorney and contracts, certificates of release, analysis and quality of medicinal products, instructions for medical use, clinical study protocols, validation of analytical procedures, finished product specifications, information about experts and other regulatory and medical documents.
We recommend PROFPEREKLAD Translation Agency as a reliable partner that meets the expectations of demanding customers.
We regularly address to PROFPEREKLAD for translation of pharmaceutical and medical documents, in particular, clinical study protocols, regulatory and quality control documentation, as well as legal documents.
AstraZeneca Ukraine recommends PROFPEREKLAD Translation Agency as the best agency on translation services market in terms of price/quality ratio.
We would also like to emphasise the urgent translation made with respect for the deadlines and work with the presentations that needed complex layout of graphic images translated.
BIONORICA LLC recommends Profpereklad as a reliable medical translation service provider.
Place your order with us and consider it “job done”!
Here is an example of a project we have recently completed, which demonstrates how coordinated and thorough our operating approach is.
A Case Study
We were contacted by our client, a Ukrainian pharmaceutical company manufacturing innovative high-tech products.
The project required translation of 230,000 words (approximately 1,000 pages) of preclinical and clinical trial materials into English in 15 business days. Given the volume and the deadline, this was rather a challenging translation task.
How did we approach the task?
The assigned team included: two project managers, three expert translators, and three expert reviewers, a proofreader, a software engineer, and three DTP specialists.
As the source documents were scanned copies of poor quality, they had to be prepared for translation. Therefore, we arranged for our DTP specialists to recreate the source documents as properly formatted, editable Word files.
The main challenge was that the project had to be divided among several translators, who could translate the same terms differently.
So, to ensure consistency in the terminology, all three translators worked on the SDL Trados GroupShare server, a programme that automatically stores any termbases within the project, preventing any inconsistencies.
Before it was delivered to the client, the completed translation had been reviewed by our reviewers who had a medical degree and an extensive experience of working together with major pharmaceutical companies, e.g. Sanofi, GSK, AstraZeneca, Darnitsa, etc.
In the end, we completed the project in a timely manner and at the level of quality that fully complied with the client’s instructions and preferences.
Moreover, while working on the above project translating into English, we also performed another project for the same client, translating 475,000 words (or 2,050 pages) from Ukrainian into Russian. Also delivered on time.
Judging by their testimonials, our clients trust our professionalism and reliability as providers of translation services for the life science, pharmaceutical, and medical device industries. We have worked with major Ukrainian exporters of medicinal products and multinational companies, including some of the Top 10 pharmaceutical companies in the world.
In addition to professional translation, we offer to our loyal clients some additional services, including term management, desktop publishing of translated documents to match the original design and format, certification of translation, and notarisation of certified translated documents.