RABT provides expert regulatory affairs services to the global life sciences industry, helping clients reduce costs and speed time-to-market through flexible, insight-driven solutions.

Our onshore and offshore blended model ensures tailored support for every client, offering visibility, compliance, and operational efficiency.

Our Expertise

Clinical & Non-clinical Services

  • Toxicological risk assessment
  • Aggregate report services
  • ICSR services
  • Literature monitoring
  • Benefit-risk evaluation reports
  • Adverse drug experience

Label & Artwork Services

  • Graphic design & proofreading
  • Content to carton conversion
  • Global labeling
  • Regional labeling for US, EU, ROW

eCTD Publishing

  • Global publishing & submission
  • NeeS submissions
  • Legacy conversions
  • CSR publishing
  • Structured product labeling
  • Regulated submissions

LCM Services

  • ANDA, NDS, MAA, NDA support
  • New product authorizations
  • API and finished product support
Quick Enquiry
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