Biotechnology Translation Services

Language Scientific is the only translation company with deep biotechnology, regulatory and language understanding that enables customized, reliable and timely completion of each translation.

Biotechnology Translation Expertise

Pharmaceutical companies, clinical research organizations (CROs), manufacturers of medical and surgical devices, biotech companies and healthcare managers have come to rely on Language Scientific for translation of their most sensitive documents. Our unique methodology that clients depend on delivers consistently clear, accurate translation of high-value information.

Clients we Serve

Our clients in this industry range from Fortune 100 multinationals, such as Merck, Novartis, Stryker and Pfizer, to small and mid-size rapidly globalizing technology and biopharmaceutical companies, such as Amgen, Mettler-Toledo, Emergo Group and Tektronix.

Meeting Regulatory Compliance

Biotechnology translation requires precision and up-to-date technical knowledge by every member of your translation team. It also requires multiple levels of quality control and a full understanding of stringent regulatory laws, especially the US, the European Union and Japan.

Whether translating patient case report forms for FDA submission or packaging for in-vitro devices to comply with the EU’s IVDD directive, there can be no compromise where the spheres of language and healthcare regulation converge. That is why our translations are translated and Certified for Translation Accuracy by Medical Professionals.

Language Scientific’s Quality Management System is ISO 9001:2015 and ISO 17100:2015 certified.

Biotechnology Translation Experience

  • Research & Development
  • Regulatory Affairs
  • Patents
  • Registration Dossiers
  • Scientific Articles Lab Reports Validation Reports Japan’s PMDA Audit Support IND and NDA Documentation for EMEA Japan’s PMDA, and China’s SFDA Declaration Of Conformity
  • CMC Documentation Labels and Package Inserts Instructions For Use (IFUs) Case Report Forms (CRFs)
  • Adverse Event Report Forms Informed Consent Forms (ICFs)
  • Site Operations Manuals Institutional Contracts IVRS Prompts
  • Validation Reports Patient Diaries
  • Adverse Event Reports (SAEs) Video Informed Consent Patient Reported Outcomes PROs)
  • Clinical Research
  • Study Protocols IRB/Ethics Committee Submissions Clinical Trial Agreements (CTAs) Investigator Brochures eLearning
  • Multimedia Sales Training Patient Education (CMI and PHI)
  • Deviation Reports Data Sheets
  • QMS Audit Documentation
  • Sales & Marketing Websites – Professional / Consumer
  • Software and Hardware Promotional Materials Marketing Collateral Manufacturing
  • GMP Documentation SOPs Batch Records and MBRs Pharmacovigilance and Postmarketing Surveillance Patient Recruitment Materials
  • Patient Questionnaires

Biotechnology Translation Services

Language Scientific specializes in providing Biotechnology Translation services

Can you paraphrase the following sentence?

“The test suggests that the additional cannula from the visceral pleura resulted in pulmonary function improvements in the approximate range of 500% from forced expiratory volumes in one-second (FEV1) measurements.”

If you didn’t have a background in medicine, you probably couldn’t. Translation is, fundamentally, paraphrasing. Would you entrust your FDA documentation or Adverse Event Reports to a translator without an MD?

At Language Scientific, we hold to the principle:

“If You Don’t Understand It, You Cannot Translate It!”

That is why Language Scientific requires all Medical Translators and Translation Editors have education, training and work experience in the Life Science Industry matching the subject matter they translate. Our meticulous Quality Control system is the most thorough in the industry, with a system of checks and balances in place throughout the entire process—from the selection of project managers to the final proofreading of the translated document.

Translation Capabilities

Regulatory

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  • Specialized in translating regulatory compliance documents for medical and surgical devices.
  • Expertise in translating EU and Asian market regulations.
  • Support for package inserts, labels, and other crucial documents for regulatory approval.

Clinical

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  • Comprehensive translation for clinical trials and research protocols.
  • Translation of Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
  • Support for translating case report forms, patient consent forms, and clinical study reports.

Marketing

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  • Adapt marketing materials with a focus on cultural relevance and impactful messaging.
  • Specialized transcreation services to ensure your brand resonates with global audiences.
  • Translation of brochures, promotional content, and digital campaigns

Operations

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  • Expertise in translating manufacturing process descriptions for medical devices.
  • Translation of standard operating procedures and maintenance manuals.
  • Comprehensive support for global operational documents to ensure accuracy across markets​

Life Science Subjects We Translate

We have vast experience translating Life Science documents in a wide variety of scientific fields. For example, in the past three years we translated medical documents, clinical data and medical device software in the fields of:
  • Adverse Event Source Documents
  • Biotechnology
  • Genetics
  • Oncology
  • Anatomy
  • Botany
  • Genomics
  • Optometry
  • Biomedical science
  • Cell biology
  • Health sciences
  • Parasitology
  • Biochemistry
  • Cognitive neuroscience
  • Immunogenetics
  • Pathology
  • Biocomputers
  • Computational neuroscience
  • Immunology
  • Pharmacogenomics
  • Biocontrol
  • Conservation biology
  • Immunotherapy
  • Pharmacology
  • Biodynamics
  • Developmental biology
  • Marine biology
  • Physiology
  • Bioinformatics
  • Ecology
  • Medical devices
  • Population dynamics
  • Biology
  • Ethology
  • Medical imaging
  • Proteomics
  • Biomaterials
  • Environmental science
  • Microbiology
  • Sports science
  • Biomechanics
  • Evolutionary biology
  • Molecular biology
  • Structural biology
  • Biomonitoring
  • Evolutionary genetics
  • Neuroethology
  • Systems biology
  • Biophysics
  • Food science
  • Neuroscience
  • Zoology
  • Biopolymers

Linguistic Validation of Clinical Instruments and PROs

Patient Reported Outcomes (PROs) questionnaires are a critical tool for gathering valuable insight into symptoms, side effects and safety of investigational drugs, and these questionnaires are widely used in global clinical trials. However, the instruments’ validity across international sites requires not just translation and cultural adaptation, but linguistic validation and harmonization across languages and locales. Language Scientific has provided Linguistic Validation of Patient Reported Outcomes (PRO) questionnaires and other clinical instruments for over 15 years. We have translated questionnaires into over 60 world languages.

The Role of AI in Biotechnology Translation

AI is redefining biotechnology translation by ensuring accuracy, speed and regulatory compliance. Our AI-optimized translation solutions streamline the translation of complex medical documentation, enabling clear communication across the globe. By combining AI efficiency with expert human review, biotechnology companies can deliver precise, reliable translations that meet the highest regulatory standards.