The Undisputed Leader in Linguistic Validation

Regulatory Documentation

When it comes to regulatory documentation for pharmaceutical products, absolute accuracy is everything. Precise translation of information such as prescribing information and packaging enables safe patient outcomes. But without an experienced partner to help you navigate the regulatory process, compliance can be a challenge. Mapi proudly offers regulatory documentation services designed to help you overcome regulatory hurdles, maintain the highest standards and meet every deadline.

Guiding global compliance

From facilitating successful global product launches to working with non-US companies to ensure Sarbanes-Oxley Act compliance, MAPI offers service and technology specifically designed to address compliance issues in the global marketplace and provide the highest standard of support. Only MAPI can deliver this level of expertise:

  • Demonstrated experience: Aided hundreds products through the regulatory process
  • Linguistic mastery: Over 170 languages, 2,500 PRO instruments translated
  • Global expertise: Over 1,000 PRO linguistic experts in over 100 countries
  • Leadership: Editor, Linguistic Validation Manual – the cross-cultural adaptation reference
  • Extensive knowledge: Coverage of all therapeutic areas

With our comprehensive knowledge of regulatory authority requirements, we confirm that your instruments are compliant. We ensure that your PROs, ObsROs, PerfOs and ClinROs are easily understood and correctly interpreted in all countries, however rare the language. We guarantee that your study data can be easily pooled and globally compared regardless of where in the world your clinical trials are performed.

Proven regulatory affairs expertise

Our commitment to excellence has allowed us to work with the top pharmaceutical and biotechnology companies in the world, successfully guiding them through the often-complex
regulatory process. They know we’re uniquely positioned to handle projects with global complexity and deliver superior results.

Meeting global consistency standards with ISO 17100 certification

The global marketplace demands consistency in high-quality medical translation services. Our ISO 17100 certification demonstrates our ability to deliver the highest quality translation services on the highest international level.

Linguistic Validation
Pre-production processes, conceptual analysis, forward translation, backward translation, cognitive interview, clinician review, proofreading and finalization, postproduction processes
Medical Translation
Translation services, editing, proofreading, back translation, expert review, transcription, voice over and DTP for medical documentation

When every moment counts

A delay in regulatory documentation could mean a delay in an important medication making it to market. Mapi is committed to responsiveness and timeliness—all of our regulatory documentation quotes are delivered quickly and accurately. Our highest priority is ensuring that your project always gets the attention it deserves.

Choose Mapi for your regulatory documentation needs

When you need unsurpassed knowledge of the clinical documentation world and an extensive network of skilled professionals with a superior understanding of the needs and challenges you face, choose Mapi. Visit mapigroup.com to get started today.

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