Predictable, value-based pricing for MedTech and clinical research teams who can't afford a flawed regulatory submission.
Word-count pricing treats a 5,000-word Instructions for Use document like a 5,000-word marketing brochure. Regulatory submissions don't work that way. One rejected EMA dossier can delay launch by 6–12 months and cost more than your entire localization budget for the year. We price for the outcome you're actually buying: a submission-ready file that survives regulatory review.
| FDA/EMA Compliance Terminology and formatting aligned to current regulatory standards. | Reduced Submission Risk MD-led validation catches issues before reviewers do. | Speed-to-Market Predictable timelines built around your submission deadlines. | Clinical SME Review Every file checked by a subject-matter expert, not just a linguist. |
Two ways to work with us, depending on whether you have a discrete submission or an ongoing localization program.
Whether you engage us for one project or a full year, every deliverable meets the same baseline.
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Strict Regulatory Alignment Output mapped to FDA, EMA, MDR, and ICH requirements. |
Clinical Authority Founded and overseen by an MD-linguist. Medical accuracy is non-negotiable. |
Data Security ISO-aligned workflows, NDA by default, GDPR/HIPAA-compatible handling. |
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Translation Memory & Glossary You own the linguistic assets we build with you. |
Submission-Ready Formatting DTP and validation included, not billed separately. |
24-Hour Response Every inquiry gets a real human reply within one business day. |
Send us a brief description of your project — typical volume, target markets, and submission timeline. We'll come back within 24 hours with a recommendation and a fixed quote.
Get a Fixed Quote in 24 Hours