Pharmaceutical Regulatory Translation Services for Global Compliance
Accurate, compliant translations of regulatory documents by subject-matter experts.
Professional Pharmaceutical Regulatory Translation Services
Navigating global pharmaceutical regulations requires precision and expertise. Our specialized regulatory translation services ensure your submissions, safety reports, and labeling documents meet stringent FDA, EMA, PMDA, NMPA, and international compliance standards. With subject-matter experts who understand both language and life sciences, we deliver accurate, compliant translations that accelerate your time to market while maintaining regulatory integrity.
Trust EC Innovations for end-to-end regulatory translation solutions that combine linguistic excellence with deep pharmaceutical industry knowledge.
Service Areas
Labelling
Our comprehensive labelling translation services cover all aspects of product information, including package inserts, outer packaging, and patient information leaflets. We ensure precise translation of dosage instructions, contraindications, side effects, and storage conditions while maintaining compliance with specific regional regulations from FDA, EMA, PMDA, NMPA, and other global health authorities.
Regulatory Affairs
We provide end-to-end translation solutions for the entire regulatory submission process, from initial investigational applications to full marketing authorization dossiers. Our team handles complex documentation including clinical study reports, non-clinical summaries, and quality overall summaries, ensuring accurate terminology and compliance with evolving regulatory requirements across all target markets.
Safety
Our pharmacovigilance translation services encompass all safety documentation requirements, including individual case safety reports, periodic safety update reports, and risk management plans. We maintain strict adherence to regulatory timelines and reporting requirements while ensuring accurate transmission of safety information across languages and regions.
What types of regulatory documentation do we translate?
Regulatory Submissions:
Pharmacovigilance and Safety Documents:
Quality Assurance and Manufacturing Documents:
Patient Information:
Scientific and Technical Documents:
Legal and Compliance Documents:
Quality Control and Assurance Documents:
Marketing and Promotional Materials:
Training Materials:
Ensure Global Compliance with Expert Regulatory Translation
Strengths
Why Choose Our Pharmaceutical Regulatory Translation Services?
EC Innovations vs. Typical Localization Providers
| Comparison Criteria | EC Innovations Advantages | Typical Provider Limitations |
|---|---|---|
| Regulatory Expertise | ✅ In-country subject-matter experts for pharma regulations | ❌ Often use generalist translators without regulatory background |
| Quality Assurance | ✅ ISO 17100 & ISO 9001 certified processes | ❌ May lack standardized quality frameworks |
| Technology Integration | ✅ TBMS Cloud glossary and CAT tool integration | ❌ Inconsistent terminology across projects |
| Compliance Focus | ✅ Deep understanding of FDA, EMA, and other agencies | ❌ Limited awareness of regional regulatory nuances |
| Confidentiality | ✅ Secure handling of sensitive regulatory documents | ❌ May not adhere to strict data security protocols |
About EC Innovations
As a globally recognized language service provider, EC Innovations has deep roots in Southeast Asia. Our Singapore office serves as the regional hub for healthcare translation, offering unmatched expertise in medical, regulatory, and patient-content localization for APAC markets.
Subject Matter Experts and Translation Teams in Pharmaceutical Regulations
Our linguists are native speakers with advanced expertise in pharmaceutical regulatory affairs, compliance, and life sciences. They combine linguistic skill with industry knowledge to deliver accurate, compliant translations.
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Subject-matter experts (SMEs)
With appropriate industry backgrounds,meet SMEs with extensive experience of document translation. They support terminology translation and maintenance while answering any technical questions translators may have.
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Qualified translators
All our translators receive thoroughgoing assessment based on our Translation Quality Report (TQR). We also take the trouble to match translators to particular clients and product lines, to see that their knowledge of your business – and hence their utility on your projects – is always growing.
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Experienced editors
With years of experience in document translation, EC Innovations’ editors use our cloud-based Computer-assisted Translation tool to review and make edits in real time. Generating feedback and approvals in the shortest possible time-frame.
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Exacting proofreaders
Background knowledge in the relevant field allows our proofreaders to play the part of end users. They always review translations with a fresh eye, and without reference to source content.
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Quality assurance reviewer
Our QA team samples 10% to 20% of total translations. Clients get independent verification of quality – and immediate identification of any issues.
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In-country reviewers or third-party reviewers
Always available on request to serve as further guarantors of translation quality.
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In-country language leaders
These key individuals work closely with translator recruitment and management to build dedicated teams of translators for each client.
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Multilingual desktop publishing team
Readying translated documents for publication in the correct format, to ensure compliance.
CERTIFICATION
ISO Certified
We are one of the few language service providers in the world that holds ISO 9001, ISO 17100, ISO 27001, and ISO 14001 certifications.
We attach a high degree of importance to the delivery and quality assurance process of translation services. For EC Innovations, providing quality services has always been the guiding force behind our corporate values and beliefs. We do this by implementing rigorous and comprehensive quality assurance procedures, following comprehensive guidelines and checklists embedded throughout the entire project lifecycle. Tasks with substandard results will be reworked until the required quality level is achieved.
ISO 9001
ISO 17100
ISO 27001
ISO 14001
How do you ensure regulatory compliance in translations?
We use subject-matter experts familiar with FDA, EMA, and other regulatory requirements, and follow strict quality assurance processes.
Can you handle urgent regulatory submission translations?
Yes, we have dedicated teams and processes to manage tight deadlines without compromising quality.
Do you translate patient-facing materials like PILs?
Absolutely. We ensure patient information is clear, accurate, and culturally appropriate.
How do you manage terminology consistency in large projects?
We use TBMS Cloud for glossary management and employ linguists familiar with your product terminology.
Are your translators certified for regulatory work?
Yes, our linguists are native speakers with subject-matter expertise and often hold relevant certifications.
What quality assurance processes do you follow?
We follow ISO-certified processes including translation, editing, proofreading, and in-country review.
Can you handle documents in various formats?
Yes, we support all major file formats and provide desktop publishing services if needed.
How do you ensure data security for confidential documents?
We adhere to strict data security protocols and can sign NDAs to ensure confidentiality.
Do you offer certification for translated regulatory documents?
Yes, we provide certified translations when required for regulatory submissions.
What makes your regulatory translation services different?
Our combination of subject-matter expertise, quality processes, and regulatory knowledge ensures accurate, compliant translations.
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Get in touch
Need expert pharmaceutical regulatory translation? Contact our subject-matter experts for accurate, compliant solutions. Request a quote today.