Pharmaceutical

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Relieving Language and Regulatory Pains

Are you preparing to submit an Investigational Medicinal Product Dossier (IMPD) for clinical trials, a Marketing Authorization Application (MAA) to market for a new drug, or a Summary of Product Characteristics (SmPC) to provide key product information for healthcare professionals?

Overwhelmed by the large-volume content? Confused by the stringent, variable language requirements of different regulatory bodies? Stressed by the tight deadlines and the shift towards digitizing documents and translations?

With many years of experience in providing comprehensive language services tailored to biotech companies, R&D companies, and Contract Manufacturing Organizations (CMOs), Transbridge understands the nuances of the pharmaceutical industry and brings together AI-driven technologies, a huge talent pool of pharmaceutical translators, deep knowledge of regulatory compliance requirements, and a rigorous, ISO-certified quality assurance process to ensure the immaculate accuracy and optimal efficiency required to accommodate the distinctive challenges of the pharmaceutical industry.

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Why Transbridge is Trusted by Leading Pharmaceutical Companies?

Compliant Pharma Translations for Every Stage of the Pharmaceutical Lifecycle

From clinical trials and pre-approvals to post-approvals and product launch, Transbridge supports every step of the pharmaceutical lifecycle by delivering fully compliant, impeccably accurate pharma translations.

Backed by a vast global network of veteran linguists, we assign your translation project only to native-speaking linguists with extensive experience in pharmaceutical translations.

With profound knowledge of the pharmaceutical terminology and the different regulatory language requirements, a meticulous 3-eyed quality assurance process, and certified legal translations authorized by the UAE Ministry of Justice, we deliver unrivalled-quality pharmaceutical translations that are faithful to the original and customized to meet the strict requirements of regulatory bodies in the pre-approval stage and ensure cultural adaptation of marketing and promotional material in the post-approvalphase.

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Safeguarding Patient Health with ISO-Certified Quality

The slightest mistake in translating pharmaceutical documents such as Patient Recruitment Materials, Standard Operating Procedures (SOPs), Packaging Inserts, and Dosage Instructions, can lead to severe consequences including health risks, legal issues, financial losses, and invalidation of clinical trials.

As an ISO-Certified (ISO 17100, ISO 9001, and ISO 20771) language service provider, Transbridge implements strict quality control processes, interweaved into every step of our workflow, to guarantee maximum accuracy and absolute consistency, ensuring clear and effective communication with healthcare professionals, patients, and regulatory bodies across 200+ languages.

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Our Quality Pillars

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Certified Translators

(with a stamp and official recognition)

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ISO-Certified Quality Management System (QMS)

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Cutting-Edge Translation Memory (TM)

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Subject-Matter Experts (SMEs)

Specializing in pharma translations

Common or Rare Languages, Large or Small Volume—Fast Turnarounds Guaranteed

Our pharmaceutical translation services cover European, African, Middle-Eastern, Latin, and Asian languages with a huge, global network of expert linguists who speak not only common, but also rare languages.

Wherever your clinical trial is to be conducted, whatever language your patients speak, Transbridge has the scalability and resources to help you cross language and regulatory barriers and access the global market faster.

We make sure you always meet the tight deadlines of the pharmaceutical industry regardless of the scale or complexity of your translation project.

  • Top-notch Translation Memory (TM) tools to ensure consistency of pharmaceutical terminology across all languages, expedite and automate workflow, and cut down on costs.
  • A team of dedicated project managers and 24/7/365 customer support.
  • Agile workflow and Translation Management System (TMS) that allow for multiple linguists to simultaneously work on large-volume content.
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    Clinical Trials & Pre-Approval

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    Informed Consent Forms (ICF)

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    Clinical Trial Protocols

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    Case Report Forms (CRF)

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    Adverse Event Reports

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    Patient Recruitment Materials

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    Clinical Study Reports (CSR)

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    Common Technical Document (CTD) modules

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    Investigational New Drug (IND) applications

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    New Drug Applications (NDA)

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    Pharmacovigilance Reports

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    Product Information Leaflets (PIL)

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    Summary of Product Characteristics (SmPC)

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    Clinical Overviews

    Labeling and Packaging

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    Packaging Inserts

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    Labels (Primary and Secondary)

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    Instructions for Use (IFUs)

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    Product Data Sheets

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    Medication Guides

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    Dosage Instructions

    Post-Approval and Marketing

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    Marketing Authorization Applications (MAA)

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    Promotional and Marketing Materials

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    Patient Education Materials

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    E-learning Content

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    Safety Data Sheets (SDS)

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    Periodic Safety Update Reports (PSUR)

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    Individual Case Safety Reports (ICSR)

    Our Tailored Language Solutions for the Pharmaceutical Industry

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