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Medical Writing

Medical writing expertise in 250+ languages, from regulatory, publication, and safety writing services to medico-marketing solutions

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The medical writing industry is growing rapidly with a CAGR of approximately 10%, and is the fourth most outsourced function. There is an increasing need for access to highly skilled writers with excellent co-authoring skills to deliver high quality documents with consistent, objective messaging. CSOFT’s medical writers bring excellent co-authoring skills, strong therapeutic and statistical expertise, and a deep understanding of the relevant guidelines and best practices to their work in the regulatory safety, publication, and marketing areas of medical writing.

The complexities of medical writing are astonishing

Our world-class medical writing services offer:

  • Skilled resources available in all time zones, enabling faster turnaround
  • Project Management and document ownership expertise
  • Strong quality review processes
  • Expertise in 250+ languages
  • Guidance to support regulatory submissions
CSOFT’s teams are trained on the diverse document types, therapeutic areas, templates and style guides that are required across phases 1 to 4, while our multi-lingual translation capabilities enable rapid cross-border market access. We are dedicated to delivering concise, clear, high-quality documentation to help drive rapid and timely regulatory approvals, enhance acceptance rates in peer-reviewed journals, and support timely market launch activities.

In addition, CSOFT provides medical editing services, helping you format and edit regulatory and publication documents to ensure compliance with style guides and templates, grammar, and formatting.

CSOFT offers flexible, customized business solutions, serving as an extended arm with teams dedicated to your needs. Our flexibility enables us to handle individual projects on pressing timelines, a demand routinely associated with medical writing. We also have the experience and expertise in rapidly establishing and scaling up FSP operations and can provide offshore support across time zones as well.

Quality Assurance

CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards.  CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.

Learn more about our quality assurance process.

Data Security

With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.

Learn more about how CSOFT prioritizes data security.


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