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Turnaround depends on document complexity. Simple documents like case narratives and abstracts are delivered within 7-8 working days. Complex regulatory documents like CSR, CTD modules, and Investigator Brochures typically take 7 to 15 business days. Expedited timelines are available on request.
Yes. We sign a Non-Disclosure Agreement before any project discussion or document sharing. Confidentiality is non-negotiable for us.
We work in compliance with ICH-GCP, ICH-E2A, ICH-E2C, ICH-E2D, ICH-E2F, FDA guidance documents, EMA guidelines, and CDSCO regulations, depending on your submission target geography.
Absolutely. CDSCO submissions are one of our core strengths. We are deeply familiar with the Indian regulatory landscape and regularly assist clients with CDSCO-compliant documentation.
Yes. We specifically designed flexible, modular service packages for early-stage startups. You can start with a single document and scale as your pipeline grows. Contact us to discuss your budget.
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Scientific Publication Support

Scientific Publication Support

Background A research group sought assistance in converting study findings into publication-ready...

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Accelerating Regulatory Submission Timelines

Accelerating Regulatory Submission Timelines

Background A mid-sized pharmaceutical company was preparing a regulatory submission for a...

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Investigator Brochure Development for a Clinical Trial

Investigator Brochure Development for a Clinical Trial

Background A clinical research sponsor required an updated Investigator Brochure for a...

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