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Regulatory Translation Services

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Regulatory Translation Services

Pharmaceutical Regulatory Translations with  Precision, Compliance, and Technical Accuracy

Experienced pharmaceutical regulatory translations from an agency you can trust

From clinical trial documentation to drug labels, we understand the criticality of maintaining accuracy and compliance within the pharmaceutical sector. Our commitment to linguistic excellence and adherence to regulatory specifications guarantees that your content is delivered with utmost precision, enabling seamless communication across diverse linguistic landscapes.

Experience the assurance of reliable and precise pharmaceutical translations tailored to meet the demands of an ever-evolving industry.

Our professionals are familiar with current legislation, regulatory affairs requirements, and newest guidelines issued by local and international authorities.

Accuracy and Precision: Ensuring precise translation of drug information, clinical trial data, and regulatory documents is paramount. Quality translations maintain accuracy in terminology, ensuring no loss of crucial information, and reducing the risk of errors in communication.

Your Challenges, Our Inspiration: Delivering Tailored Solutions

Global Compliance: Regulatory bodies worldwide have stringent requirements. Quality translations ensure that all materials meet these standards, facilitating compliance with regulations across various markets and jurisdictions.
Patient Safety: Accurate translations on drug labels, patient information leaflets, and dosage instructions are critical for patient safety. Quality translations reduce the risk of misinterpretation or misunderstanding, thus enhancing patient care and safety.
Market Expansion: Translating pharmaceutical content effectively opens doors to new markets. Quality translations ensure that your products and research can reach a broader audience, facilitating market expansion and growth opportunities.
Maintaining Scientific Integrity: Precise translations maintain the scientific and technical integrity of research papers, clinical studies, and scientific publications. This ensures that the original meaning and intent are preserved, maintaining the credibility of the content.
Cost and Time Efficiency: Quality translations reduce the need for revisions and corrections, saving both time and resources. They minimize the chances of regulatory setbacks or misunderstandings that may result in costly delays.
Professional Reputation: Accurate translations reflect professionalism and dedication to quality, enhancing your company’s reputation within the pharmaceutical industry. This credibility is invaluable in building trust among stakeholders, including regulatory authorities and customers.

Why us?

1. Seasoned subject matter experts

  • Strict selection process for choosing pharmaceutical translators to ensure that we assign your project to the best team.
  • Ongoing training is crucial as regulations evolve; we help translators stay updated to guarantee the precision of your translations.
  • Expert project managers and translation and localization consultants who know how to communicate your requirements to the translation team.
  • Continuous evaluation – we keep track of the feedback received from clients and we work together with the translators to improve the translation.

2. Quality control

  • We adhere to the ISO 17100:2015 certification, ensuring that our core processes and resources comply with translation industry standards, guaranteeing the quality of your translations.
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3. Translation Management System

For streamlined and efficient language solutions, we use:

  • Computer-Assisted Translation (CAT) tools: We employ CAT tools throughout our translation process, ensuring consistent terminology across your documents and boosting the productivity of our pharmaceutical and medical translators.
  • Client translation memories: Upon client approval, we integrate the translation into their dedicated memory bank. This resource becomes invaluable for upcoming projects, leveraging past translations to maintain consistency across texts. Utilizing previously translated content not only ensures coherence but also leads to cost savings through discounts on recurring text segments, gradually reducing overall translation expenses.
  • Individual client glossaries: Each client receives a personalized glossary, with their preferred terms or regulatory requirements. These glossaries are seamlessly integrated into our CAT tools, ensuring uniformity and precision across the translation process.
  • Global glossaries: Our system includes glossaries sourced from the Good Manufacturing Practice, European Pharmacopoeia, United States Pharmacopeia, European Medicines Agency, and MedDRA. These readily accessible glossaries empower translators with approved terminology directly within their projects, ensuring adherence to authorized language standards.
  • Project-specific translation memories: We create translation memories based on the specifics of each project like whether for centralized or mutual recognition projects.
  • Effective time management: Our system constantly tracks translators’ progress in real-time to prevent any delays in delivering your translations.
  • Clear records: With all data securely stored within our system, you can effectively showcase compliance to regulatory authorities. Our records meticulously display the adherence to rigorous quality standards throughout the translation process, guaranteeing accuracy and complying with the industry requirements.
  • Automated workflow: Upon completion of each project phase, the document seamlessly proceeds to the next contributor automatically. This automated workflow not only saves time but also ensures optimum efficiency in the process.
  • Effortless client approval: Our system allows clients to review translations directly, streamlining the process. Approved changes are seamlessly integrated, eliminating the need for a separate team to upload them afterwards.
  • Stringent security measures: Our secure internal system prohibits the use of email for external file transfers, ensuring absolute confidentiality and safeguarding our clients’ privacy. Additionally, we implement restrictions to control translator access, preventing the download of your confidential files. All data remains exclusively within our system, and it’s these robust security measures that allow us to be ISO 27001:2013 certified.

What types of regulatory documentation do we translate?

Regulatory Submissions:

New Drug Applications (NDAs)
Marketing Authorization Applications (MAAs) 
Investigational New Drug Applications (INDs) 
Drug Master Files (DMFs)
Common Technical Documents (CTDs)

Pharmacovigilance and Safety Documents:

Adverse Event Reports (AERs)
Periodic Safety Update Reports (PSURs)
Risk Evaluation and Mitigation Strategies (REMS)

Quality Assurance and Manufacturing Documents:

Good Manufacturing Practice (GMP) Documentation
Certificates of Analysis (CoAs)
Stability Study Reports
Drug Labels and Packaging Inserts

Patient Information:

Patient Information Leaflets (PILs)
Medication Guides
Product Labels and Packaging

Scientific and Technical Documents:

Scientific Articles
Research Papers
Scientific Presentations
Manufacturing Process Descriptions 

Legal and Compliance Documents:

Patents and Intellectual Property Documents
Licensing Agreements
Regulatory Compliance Reports

Quality Control and Assurance Documents:

Quality Control Specifications
Standard Operating Procedures (SOPs)
Validation Documents

Marketing and Promotional Materials:

Marketing Authorization Holder (MAH) Communications
Promotional Brochures and Materials

Training Materials:

Training Manuals
e-Learning Courses
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Break Language Barriers with Us!

For more information, contact one of our pharmaceutical regulatory translation experts today!

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