Indegene provides a range of Regulatory Writing and Pharmacovigilance Services covering key therapeutic areas across clinical and postmarketing stages. We compile, organize, write, and edit a range of high-quality regulatory and safety documents. Our regulatory writing & safety services are cost-effective, flexible, and seamlessly integrated with the needs of various regulators and clients across the world.

• Regulatory Writing Services
• Review, compilation, and submission of registration dossiers—CTD (clinical as well as nonclinical modules) and QC of CTD modules (clinical as well as nonclinical)
• Preparation of pre-study and post-study documents—clinical trial protocols, investigators' brochures (IBs) and manuals, informed consent documents, interim and final clinical study reports (CSRs), and SAE narratives
• Safety Services
• 24 X 7 call center services to receive, respond, track, and enter data on adverse events, product quality complaints, and medical information inquires
• Safety processing and reporting
• Full assessment of serious and nonserious adverse events
• Expedited safety processing to meet US and EU regulatory reporting requirements
• Report generation: individual case safety reports, case narratives, and periodic safety reports for marketed and developmental products
• Pharmacovigilance training services: sales force training and physician training