Over our history, our team of experienced medical and language experts have accurately translated and edited millions of words of pharmaceutical product information and medical documentation.
Regulatory Affairs translation is an area where 100% accuracy and consistency are a critical requirement. One omission or a slight error in a translation could have dire consequences for the safety of patients and negatively impact the medical team advising the patient on the product features, usage, and effectiveness of the product. Your language approach can also mean the difference between authorization or denial of your regulatory submissions by the FDA and other regulatory bodies.
Our industry specialization, regulatory knowledge, and terminology expertise ensure accuracy and consistency across all your regulatory content.
Our Proven Translation Process
Accurate
Consistent
Culturally Appropriate
Compliant with Regulatory Requirements
Expertise in Regulatory Affairs Translation in over 200 Languages
We have a 28-year track record of providing pharmaceuticals, biotech, and healthcare organizations with quality, compliant multilingual communications. With BioMedica as your language partner you can be confident that you’re receiving accurate, consistent translations in a timely manner. Our global team of linguists with expertise in medical and clinical trials, project managers, and subject matter experts combine with our proven translation process and innovative technology to deliver high-value, quality while saving you on translation cost and project time.
Types of Product Documentation
- Packaging
- Labeling
- Package Insert
- Pharmaceutical Product Information
- Patient Prescribing Information
- Patient Information Leaflets (PILs)
- Common Technical Documents (CTDs)
- Package Insert
- MSDS – Material Safety Data Sheet
- Regulatory Correspondence
Types of Product Documentation
- Packaging
- Labeling
- Package Insert
- Pharmaceutical Product Information
- Patient Prescribing Information
- Patient Information Leaflets (PILs)
- Common Technical Documents (CTDs)
- Package Insert
- MSDS – Material Safety Data Sheet
- Regulatory Correspondence
Expertise in Regulatory Affairs Translation in over 200 Languages
We have a 28-year track record of providing pharmaceuticals, biotech, and healthcare organizations with quality, compliant multilingual communications. With BioMedica as your language partner you can be confident that you’re receiving accurate, consistent translations in a timely manner. Our global team of linguists with expertise in medical and clinical trials, project managers, and subject matter experts combine with our proven translation process and innovative technology to deliver high-value, quality while saving you on translation cost and project time.
Our Methodology
BioMedica has extensive experience in providing translation services of regulatory documentation to many of the top pharmaceutical companies and medical organizations. BioMedica provides a comprehensive quality assurance process that ensures this mission-critical translation meets the requirement of the regulatory bodies around the world.
To ensure full acceptance of regulatory documentation in any language, your content will go through an extensive multistep process that provides an accurate, culturally appropriate final product. The translation will be conducted by a team of experienced medical and language experts.
End-to-End Medical Translation Services
- Translation by highly qualified linguists with medical and regulatory expertise
- Editing by linguists with medical expertise
- Quality Assurance Review
- Final pre-production proofing
- In-country language review
- Notarized certification attesting to the final translation
- Multilingual multimedia production, i.e., typesetting, formatting, etc.
Our Medical and IP team are satisfied with their work, and I use their translations (Along with their notarized certifications) for our regulatory submissions. We are impressed with Global link’s discipline, quality, and commitment.