Pratiksha Gangurde

To associate myself with organization that provides challenging and opportunity to prove myself for the success of organization.

Regulatory Affairs Officer - Shivmoh Consultancy

(2024-10 - 2026-05)

• Preparation of DMF like Open Part & Close Part (Restricted Part)
• Preparation of Dossiers like CTD, ACTD & Regional dossiers for ROW (Rest of World) Markets.
• Reviewing factory documents like BMR, BPR, PVP/PVR ,Specification, Method of analysis, Certificate of analysis, Stability Data.
• Coordinate with a factory person for document

Intern - Reliable Analytical Laboratories

(2023-02 - 2023-05)

Extraction done by using instruments like HPLC, LC-MS, GC-MS, UV in various food products. There is having three months of duration gained very good knowledge and experience.

Advanced PG Diploma - Regulatory Affairs (API & Formulation) - Institute of Pharmaceutical Management (2024)

Masters - Bioanalytical Sciences - B.K.Birla College / Mumbai University (2023)

Bachelor - Lifesciences - Model College Khambhalpada / Mumbai University (2021)