I am a Clinical Research Professional with extensive project experience from concept to development & Training & Regulatory Affairs with rich 20 yrs of experience. Having in-depth knowledge of ICH - GCP, ICMR guideline, New Drugs and Clinical trials Rules 2019, Medical Device Rules, and keep updates of changing rules and regulations. Have experience of DCGI & NABH Audits.My core expertise are Project development and operations with end to end services, Regulatory Affairs, Screening and Recruitment, Detailed documentation, Audits, SOP development, Registration & Administration of Ethics Committees, NABH accreditation of Clinical site & Ethics Committees. Project Management, Event management, Coordination, Human Resource activity, Budget ,Time Management. Documents filling & Archival as per regulatory norms.