Jagdeep Kumar Email & Phone Number

India

Drug Regulatory affairs, handling team size of 50 plus including executives, sr. executives, asst. managers. Meetings with Client, FDA/MOH officials. Experienced with Appointment 2000 plus applications & approvals across the world for drug registration, Queries, variations, post approval compliances etc.

Delhi, India

Leading DRA team of 30 plus. CTD, ACTD, BE, CT, CMC, PSUR, SPC, ROW countries. More than 500 registrations/ DRC across the world.

New Delhi, Mukherjee Nagar

drug regulatory affairs, handled team size of 15 plus including executives, Sr. executives.

Nehru Place, Delhi

1. Dossier compilation and preparation as per ACTD, CTD and Regional format for various formulations like ORAL- Tablets, Capsules, Granules, Syrups, Suspension, TOPICAL- Ointment, Paste, Lotions, Creams, Gel, INJECTIONS and Ophthalmic etc. for Following countries: Latin American countries- Guatemala, Costa Rica, Panama, Venezuela & Honduras, El Salvador..

Delhi-9, Mukherjee Nagar

dossier compilation for latin and CIS countries. CMC,Clinical and Non clinical documents review, Queries reply, variation application etc.

Ring Road Mall, Sector 3, Mangalam Place, Sector 3, Rohini, New Delhi, Delhi 110

• Preparation of Dossiers for new drug approval (form 44), BE for export applications.
• Critical review, checking of bioequivalence protocols and BE reports.
• Critical review & submission of Toxicity reports.
• Critical review & PSUR preparation for DCGI submission.
• Critical review, checking of clinical trial protocols and Clinical trial reports.
• Preparation of therapeutic rationale and justification for fixed dose combinations.

Derabassi, Distt. Mohali (Punjab)

Preparation and Compilation of Quality Documents Like BMR, BPR etc.