We help pharmaceutical companies and CROs ensure accuracy and regulatory compliance throughout the drug development lifecycle so that safe and effective treatments reach patients worldwide.
Are you a pharmaceutical company or a contract research organisation handling critical information in a number of languages? As your pharmaceutical translation partner, we understand the complexities of your industry and the stringent regulatory requirements for importing and distributing pharmaceutical products in the EU.
From development to regulatory approval, every document must be accurate, coherent, and tailored to the needs of regulatory bodies, specialists, and patients alike. Our specialised pharmaceutical translation services are designed to support you at every stage of the drug life cycle, ensuring precision and compliance throughout the process. We understand the regulatory requirements like few other translation providers can.
Why We Are Your Ideal Partner for Pharmaceutical Translation
Expertise in Drug Regulatory Affairs
With extensive experience in European drug regulatory affairs, we manage a wide range of documents for all marketing authorisation procedures (centralised, decentralised, mutual recognition, and national). Our deep understanding of EMA and national authority requirements ensures seamless compliance across all submissions.
Vetted Pharmaceutical Linguists
Our team of 300+ pharmaceutical translators is carefully vetted and trained in EMA’s QRD templates, EDQM Standard Terms, and MedDRA, covering all EU/EEA languages to deliver translations rapidly without compromising quality.
Stringent Quality Assurance
We follow a rigorous ISO 17100 project life cycle, ensuring your translations meet industry and regulatory standards. Our multi-step review process guarantees that your documents will be accepted by EMA and national authorities.
Proven Track Record
Our clients trust us for our flexibility, professionalism, and extensive industry knowledge. With Mastermind Translations, your pharmaceutical translation projects are in safe hands.
Pharmaceutical content we translate:
Discovery Phase: patents, scientific publications, Good Laboratories Practice (GLP) documents, pharmacology and toxicology reports, Standard Operating Procedure (SOP) documents, Pharmaceutical Development (CMC) documents
Clinical Research Phase: clinical study protocols, investigator’s brochures, training material, Ethics Committee papers, Inform Consent Forms (ICFs), Case Report Forms (CRFs), Good Clinical Practice (GCP) documents, clinical trial reports, patient records, Patient-Reported Outcomes (PROs), marketing applications, clinical trial authorisations
Marketing Authorisation Phase: Summaries of Product Characteristics (SPCs), Patient Information Leaflets (PILs), package labels, European Public Assessment Reports (EPARs), Periodic Safety Update Reports (PSURs)
What Our Clients Say About Our Pharmaceutical Translation Services
This is super helpful. I really appreciate your assistance and look forward to working with you should I have future translation requirements.
Pharmacovigilance Team Leader JensonR+ Limited
I would like to express our sincere gratitude for your professionalism, loyalty, and support with our projects, in both my name and on behalf of my whole team (at least the colleagues you have had the chance to work with). I just wanted to thank you for your attentiveness to medac as your client, and effort for the selection of expert linguists. That is of another level. I really appreciate it and am glad we have you as a partner.
