Regulatory Affairs/writing

Regulatory writing is a critical component of drug development. Regulatory Writers provide medical writing and project management services to ensure that high-quality, submission-ready paperwork is delivered on time. The documents we assist span all stages of drug development, starting from protocol writings to clinical trials to marketing approval.

Our expert team assists clients with various aspects of regulatory affairs/writing:

  • Development of high quality clinical and safety documents such as Clinical Study Reports (CSR), Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and other submission documents
  • Common Technical Document (CTD) preparation and Investigator Brochures (IBs)
  • Scientific driven regulatory writing
  • Chemistry, Manufacturing, and Controls (CMC) regulatorystrategy
  • Target Product Profiles (TPPs)
  • Regulatory submissions


Pharmaceutical technology undergoes rigorous safety and efficacy testing through clinical trials before market authorization and use. Due to some limitations inherent in clinical trials, certain side effects/adverse events may only become apparent after these products have been used by a diverse population, including people with other concurrent diseases, for an extended period of time. In this scenario, pharmacovigilance assists healthcare practitioners and decision/policy makers in understanding the science and activities associated with the detection, assessment, and prevention of adverse effects or any other problem associated with medicine/vaccine.

Our pharmacovigilance expert team helps clients in various aspects:

  • End to end case processing services
  • Periodic safety assessment and reports
  • Review and preparation of safety data exchange agreements (SDEAs)
  • Literature search and report writing (e.g. PSUR)
  • Conduct preliminary case assessments, data entry, MedDRA coding, medical/casereview, report assessment, quality check