: info@anregenhealthcare.com
: +91-11- 40563752

Regulatory, Scientific Affairs and Pharmacovigilance

Regulatory services

We guide you through the initial marketing authorization application, helping you to achieve approval to bring a newly developed drug to market. With professionals in all aspects of regulatory affairs, we provide customer-specific strategies, consultation & customer onsite support, regulatory information management and eCTD / esubmissions for all the regulated markets.

Development Consulting & Scientific Affairs

Ourscientific services includes development strategy and gap analysis, clinical and non-clinical trial designs, health authority briefing documents, scientific advice and health authority meetings, due diligence, CTD clinical & nonclinical documents, paediatric investigation plans / paediatric study plans, orphan drug designations, toxicological evaluations, environmental risk assessment.

Pharmacovigilance

Pharmacovigilance services includes: ICSR management, on-going monitoring and signal management, literature surveillance services, risk management, periodic safety update reports, safety data exchange agreements, pharmacovigilance quality system set-up, audit and inspection support, EU-QPPV / local QPPV.