Regulatory Affairs & Pharmacovigilance

• 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

Pharmacovigilance

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