Medical Writing and Translation

Regulatory medical writing and translation plays an important role for the regulatory submission documents during the drug development process and defines the success of novel pharmaceutical products. To ensure precise and timely submissions of relevant document packages, Creative Biolabs is committed to becoming your preferred partner to avoid any delays of submission and profit realization.

Regulatory Medical Writing Service

Empowered by a qualified team of experienced and skilled medical writing professionals with both research and pharmaceutical backgrounds, Creative Biolabs provides a full spectrum of regulatory medical writing services, including developing quality documents, performing peer review and coordinating client review, conducting quality checks and accomplishing the program management of a wide range of regulatory writing activities in both electronic Common Technical Document (eCTD) and CTD modules.

Capabilities

  • ✔ Clinical overviews (eCTD Module 2.5) including literature review and references
  • ✔ Clinical summaries (eCTD Module 2.7) including clinical pharmacology, efficacy, and safety
  • ✔ Clinical study report preparation and review (eCTD Module 5)
  • ✔ Clinical justification documents for EU, US and other emerging Regulatory markets
  • ✔ Gap analysis for dossiers in clinical module
  • ✔ Clinical and nonclinical document support, handling queries during HA meetings and responding to them
  • ✔ Technical review dossiers
  • ✔ Biowaiver support and justification document services

Our medical writing team has demonstrated proficiency in delivering superior regulatory medical and scientific writing services for pharmaceutical and biotechnology companies worldwide in accordance with strict timelines and high-quality parameters. We also ensure that the writing is in line with the corresponding studies.

Translation Service

As a regulatory translation specialist, Creative Biolabs is dedicated to delivering high-quality translation services to clients around the world, which always fit your timeline within budget requirements. We have extensive experience in regulatory documents including CTD dossiers, labelling, SmPCs, validation protocols, PILs, and Instructions for Use etc. To facilitate your dossier package preparation. We offer comprehensive regulatory translation services which cover all documents involved in the registration process. Here are the most frequently translated documents but not limited to these.

  • ✔ Marketing Authorization Dossiers–CTD module 1, CTD module 2, CTD module 3, CTD module 4 and CTD module 5
  • ✔ Packaging and Labelling
  • ✔ Summary of Product Characteristics (SmPC)
  • ✔ Validation protocols
  • ✔ Patient Information Leaflet (PIL)
  • ✔ Expert reports
  • ✔ Instructions for Use

Creative Biolabs is an experienced regulatory writing and translation services provider for writing, independent quality review and technical review of dossiers, identifying gaps for already prepared or compiled dossiers, and regulatory translation. Our regulatory medical writing and translation team is committed to catering to specific requirements of various regional Health Authorities (HAs) of USA, EU, and some APAC regions including China, India and Philippines.

Any regulatory medical writing or translation requirements, please feel free to contact us for more information and a detailed quote.

For lab research only, cannot be used for any clinical use.

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