Translating Clinical Trial Protocols for Regulatory Submission
Translating clinical trial protocols for EMA, INFARMED and ANVISA submissions. Regulatory requirements, ISO 17100 quality process and amendment management.
Read moreBased in Lisbon, M21Global follows the rigorous TEP process (Translation, Editing, and Proofreading), certified by Bureau Veritas in accordance with the international standards ISO 17100 and ISO 18587. These certifications ensure that every project undergoes rigorous quality control, from translator selection to final delivery.
Bureau Veritas CertifiedCulturally relevant and fluent translations, adapted to the target market by specialised native translators.
Technically precise language, reflecting the professional image our clients wish to project.
Every project reviewed by a second professional, ensuring an additional level of accuracy.
Client-specific glossaries reviewed and approved by the client, ensuring terminological consistency.
Services tailored to each client's specific needs, adapting deadlines and incorporating feedback.
As an ISO 17100 certified translation agency, we translate technical, scientific, and legal texts, including software and websites, and legally certify documents for national and international use.
Specialised technical translations with precision and professionalism in every word. Absolute confidentiality in handling all documents.
Learn more about technical translationSpecialists in translating complex legal texts, ensuring impeccable accuracy in legal documents and contracts.
Learn more about legal translationInternational negotiation documents with accuracy in commercial agreements and contracts. Absolute confidentiality guaranteed.
Learn more about business translationExtensive experience in financial reports and account statements, ensuring precision in every detail.
Learn more about financial translationTranslations with legal certification, ensuring international recognition. Certified by lawyers or notaries.
Learn more about certified translationScientific translations with precision and fluency in articles, theses, and academic publications.
Learn more about scientific translationReceive a free quote within 3 hours. No commitment.
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Transparent and competitive quotes within 3 hours, ensuring the best value for money.
Fair prices for each service level, without compromising quality, backed by ISO certifications.
Full understanding of texts and client preferences before starting any project.
Client-specific glossaries reviewed and approved, ensuring terminological consistency.
Translations exclusively by native professionals, ensuring authenticity and cultural relevance.
Final review by a single professional, ensuring uniformity and coherence throughout the text.
Every translation reviewed by a second professional with an impartial perspective for maximum quality.
Three-phase checks: during translation, after translation, and after review.
Strict adherence to established deadlines while maintaining high quality standards.
Corrections until the client is fully satisfied, at no additional cost.
Internal analyses after each project to identify and implement service improvements.
Continuous investment in tools and solutions to maximise quality and efficiency.
Tangible results from M21Global client satisfaction surveys.
Clients who rate the service as satisfied or very satisfied.
Clients who consider it likely to recommend M21Global to other companies.
Clients who rate translation quality as satisfactory or very satisfactory.
What our clients say about our translation services.
"You managed to make the miracle happen! Thank you so much for your extraordinary work."
"Congratulations on the quality of the translation delivered and the high quality standards."
"The swift and professional manner in which the contract was translated, within the requested deadline."
"Deep gratitude for the resilience and professionalism throughout this long journey."
"We are extremely pleased with the service provided, demonstrating speed and professionalism."
"We appreciate the dedication and commitment of the team, which delivered in record time."
"Outstanding in response speed, quote delivery, and work execution."
"Very professional company with competitive prices! Highly recommended!!!"
"We strongly recommend them for quality, tight deadlines, and the variety of services offered."
"Speed in response and translation, availability for clarifications, price, and quality."
"Service of excellence. 100% recommendable."
"Professionalism demonstrated by your team — we look forward to continuing this partnership."
Answers to the most common questions about our translation services.
The price varies depending on the language pair, volume, and document complexity. We send a free, detailed quote within 3 hours, with no obligation.
ISO 17100 is the international standard that defines the requirements for quality translation services. It ensures that every project follows the TEP process — Translation, Editing, and Proofreading — with qualified native translators. M21Global is certified by Bureau Veritas.
It depends on the volume and complexity. Quotes are delivered within 3 hours and deadlines are set on a case-by-case basis, with a strict commitment to meeting them.
Yes. Our certified translations are internationally recognised and can be certified by lawyers or notaries for legal use in Portugal and abroad.
We translate across 252 language pairs, including major European, Asian, African, and American languages. All translators are native speakers of the target language.
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Translating clinical trial protocols for EMA, INFARMED and ANVISA submissions. Regulatory requirements, ISO 17100 quality process and amendment management.
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