Regulatory Affairs Translation Expertise
When Accuracy Matters?
Over our 27 years of history, we have translated and edited millions of pages of pharmaceutical product information and medical documentation.
Translating product materials accurately
The Regulatory Affairs translation is an area where 100% accuracy and consistency is 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.
Expertise in Regulatory Affairs Translation in over 250 Languages
Global Link has spent 27+ years helping pharmaceutical companies both big and small with quality, compliant multilingual content. With Global Link as their language partner, pharmaceutical companies can be confident that they are 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 combines with our proven translation process and innovative technology to deliver high-value, quality translations while saving you on translation cost and project time.
Our proven translation process provides translations that are:
· Accurate
· Consistent
· Culturally Appropriate
· Compliant with regulatory requirements
Leading life sciences organization trust Global Link with their language needs
We are experts in translating all types of pharmaceutical product documentations, including
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
Our Methodology
Global Link has extensive experience in providing translation services of regulatory documentation to many of the top pharmaceutical companies and medical organizations. Global Link provides a comprehensive quality assurance process that ensures this mission-critical translation meet the requirement of the regulatory bodies in the U.S., Europe, and Asia.
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.
· Translation by two highly qualified linguists with medical and regulatory expertise
· Editing by linguists with medical expertise
· Multilingual multimedia production, i.e., typesetting. Formatting, etc.
· Quality Assurance Review
· Final pre-production proofing
· In-country language review
· Notarized certification attesting to the final translation
Premium Services for Life Sciences
Speed
Our technology speeds up the translation process by 25%
Quality
Three-point quality assurance process ensures best possible deliverables
Expertise
27+ years expertise in the Life Sciences industry
“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.”
P. Prasad
Indegene Pharmaceutical
Why Global Link?
Experience and expertise. Over 26 years of delivering a full range of high-value, professional translation services, and localization solutions
Efficient translation management processes that are fast, scalable, and flexible
A vast network of professional translators with expertise in specific industries and subject matters
Innovative technology and in-house technology solutions.
A comprehensive quality assurance process backed by 26 years of language excellence
Professional translation services tailored to our client’s specific language needs with the utmost confidentiality, and unparalleled customer service.
Resources
Success Stories
Certified Translation and formatting of research study for FDA approval
Success Stories
Medical device translation services and voice-over of heart monitor devices.
Languages We Translate
Global Link provides professional translation services in over 250 languages. Our certified translators are native speakers of the target language and have subject matter expertise. We consistently provide high-quality, high-value translations to top brands, emerging startups, and government agencies. The list of languages by market/region should assist you in choosing your languages.
Let’s talk about your multilingual project(s)
Contact us today