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regulatory writing partner

to small and mid-size life sciences companies

about
us

Regulatory medical writing and AI workflow consulting for life sciences

our mission

AccelWrite exists to bring clinical intelligence and regulatory precision to every document that stands between a therapy and the patients who need it,

 

and to ensure that as AI reshapes how those documents are produced, the science and the standards are never compromised.

AccelWrite was founded in 2023 by Sruthi Sampathkumar on the belief that every regulatory document stands between a therapy and the patients who need it, and that the clinical intelligence, precision, and accountability brought to that document matters as much as the science behind it.

 

Built by a physician-trained regulatory medical writer with over six years of experience across CROs, pharma, and biotech, and shaped by firsthand experience across the full submission lifecycle including technical product management building AI/LLM tools, AccelWrite exists to deliver senior-level regulatory writing expertise with full ownership of every engagement.

 

As generative AI tools enter documentation pipelines faster than the governance frameworks designed to manage them, AccelWrite brings Oxford-certified expertise in AI ethics, regulation, and compliance to help life sciences teams determine where AI integration advances their submissions  and where it puts them at risk.

Sruthi Sampathkumar MBBS, founder and principal of AccelWrite LLC, regulatory medical writer

Sruthi Sampathkumar

Founder & Principal

Work With AccelWrite

Ready to discuss your regulatory writing needs?

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