Introduction
Selecting a translation vendor for pharmaceutical or medtech work requires more than comparing prices. It is essential to evaluate capabilities that ensure regulatory compliance, terminological accuracy, data security and audit traceability. Below are seven critical capabilities and a short checklist to use during selection and request-for-proposal processes.
1. Regulatory experience and sector knowledge
The vendor should have a track record with regulated content (clinical trials, technical data sheets, regulatory submissions). Familiarity with authorities such as FDA, EMA and local agencies prevents rework due to formal non-compliance.
2. Specialized team and technical reviewers
The workflow must include certified translators, linguistic reviewers and technical reviewers with clinical or pharmaceutical expertise. Final delivery should always pass a subject-matter review.
3. Documented quality control and metrics
Require clear quality procedures: checklists, automated checks and manual reviews. Ask for operational metrics (average review time, critical incident rate, rejection rate by technical review) to compare quality rigor.
4. Terminology management and translation memories
Validated glossaries and well-maintained translation memories ensure consistency and speed. Verify update policies, governance for term changes and the vendor’s ability to sync memories with client systems.
5. Information security and privacy compliance
The vendor must demonstrate security measures (encryption in transit and at rest, access controls) and sign data protection and confidentiality agreements. For projects involving personal or clinical data, confirm compliance with applicable regulations (for example HIPAA, GDPR) and options for on-premise or closed environments.
6. Integrated technologies and automation
Assess use of computer-assisted translation tools, API integrations with content platforms, and workflow management features that reduce manual errors. The ability to deliver publication-ready packages speeds time to market.
7. Traceability, change logs and audit readiness
The vendor should provide clear evidence: version histories, records of who made each change, QA reports and technical reviewer sign-offs. Audit-ready packages simplify regulatory inspections and internal reviews.
Quick selection checklist
- Demonstrable experience in pharmaceutical or medtech projects?
- CVs or certifications for technical staff and clinical reviewers?
- Documented quality process with measurable KPIs?
- Validated glossaries and maintainable translation memories?
- Clear security policies and data protection measures?
- Technology integrations (CAT tools, APIs) to streamline workflows?
- Capability to produce audit-ready evidence and deliveries?
Conclusion & next step
For regulated content, choosing a translation partner is a strategic decision that affects patient safety and regulatory compliance. Evaluating these seven capabilities reduces risk and speeds up localization adoption.
Contact us for a ready-to-use request-for-proposal template and an interview checklist to evaluate potential vendors.
