Pharmaceutical Translation Services
FDA, EMA, and PMDA compliant translations for clinical trials, regulatory submissions, and product labeling. Trusted by 50+ pharmaceutical companies worldwide.
Pharmaceutical Translation Challenges We Solve
We understand the unique complexities of pharmaceutical translation
Regulatory Compliance
Navigate complex FDA, EMA, PMDA, and NMPA requirements with translations that meet all regulatory standards.
Technical Accuracy
Ensure precise translation of complex medical terminology, drug mechanisms, and clinical data.
Tight Timelines
Meet aggressive submission deadlines without compromising quality or compliance.
Multi-Country Submissions
Coordinate simultaneous submissions across multiple regulatory agencies and languages.
Pharmaceutical Documents We Translate
Comprehensive translation services for the entire pharmaceutical product lifecycle, from R&D to commercialization.
- Clinical Trial Documentation (Protocols, ICFs, CRFs)
- Regulatory Submissions (CTD, NDA, MAA, ANDA)
- Product Labeling (SPCs, PILs, IFUs)
- Pharmacovigilance & Safety Reports
- Medical Device Documentation
- Marketing & Commercial Content
Why Choose Cethos for Pharma
- Expert LinguistsMDs, PharmDs, and PhDs in our linguist network
- Regulatory Expertise100% acceptance rate for regulatory submissions
- Fast TurnaroundRush services for urgent submissions
Frequently Asked Questions
What pharmaceutical documents do you translate?
We translate all pharmaceutical documentation including clinical trial protocols, informed consent forms, investigator brochures, regulatory submissions (CTD, NDA, MAA), product labeling (SPCs, PILs, IFUs), pharmacovigilance reports, CMC documentation, and marketing materials.
Are your translations FDA and EMA compliant?
Yes, all our pharmaceutical translations comply with FDA, EMA, PMDA, NMPA, and other regulatory requirements. We follow ICH guidelines and are ISO 17100 and ISO 9001 compliant. Our linguists are trained in regulatory requirements specific to each market.
Do you have experience with clinical trial translations?
Yes, we have supported over 500 clinical trials across 40+ therapeutic areas. Our services include translation of protocols, ICFs, CRFs, patient diaries, and all trial-related documentation. We offer back-translation and reconciliation services as required.
What is your turnaround time for regulatory submissions?
Standard turnaround is 2,000-3,000 words per day. For urgent submissions, we offer rush services with 24-hour and 48-hour turnaround options. We can scale teams for large volume submissions to meet your regulatory deadlines.
How do you ensure terminology consistency across documents?
We use translation memory (TM) technology and maintain client-specific terminology databases. Each project has a dedicated terminology manager who ensures consistency across all documents and languages throughout the product lifecycle.
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