Mukund Madhav Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Lead the post-approval regulatory submissions including labelling updates for cardiovascular products in EU and International markets.Scientific/Qualification advice with EMA & FDA for AZ pipeline product.

Bengaluru, Karnataka, India

As Reg Affairs Lead on CTA projects, led the planning, preparation and execution of Initial CTA, Amendment/Variation and EOT submissions to HA and EC at global level (Europe, APAC, LA & Canada).Managed HA/EC queries, liaised with client and PPD local team as required and provided final response for submission.Performed regulatory assessment/intelligence and molecule assessment.Provided regulatory strategy and/or technical advice to internal and external clients, and liaised in executing strategies.Led the development and implementation of project-specific processes for sponsors.Extensively collaborated with other departments within PPD, with Clients, regulatory consultants and regulatory authorities.Assisted in identifying and recognizing out of scope activities in a contract in a timely manner and liaised with other departments to follow through on all aspects of contract modification.Supported RA business development activities, including project budgeting/forecasting.

Bengaluru Area, India

Bengaluru Area, India

Performed EC submissions for US sites in alignment with the global submission strategy.Prepared Regulatory Compliance Review packages.Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and Client Company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client.Developed country and site-specific Patient Information Sheet/Informed Consent form documents.Coordinated all activities required to submit and obtain Ethics Committee (EC) opinion for new studies and amendments.Performed and coordinated activities for site identification and for execution of feasibility.Complete tracking of project related activities. Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner.

Gurgaon, India

Gurgaon, India

East Sikkim, Sikkim, India

Studied about various departments and its functions - Tablet production, IV preparations, QA, QC, IPQA, & AHU. Successfully prepared and submitted the assignment to Human Resource department.

Vadodara Area, India

Studied about different formulations, QA, QC, water plant, utility block etc and successfully completed the assessment done by QA department.

B.Pharm, Pharmaceutical Technology, 8.67/10 Cgpa

Activities and Societies: Delivered two seminars during my academics: 1) "UV Spectrophotometric estimation of telmisarton in its tablet.

Postgraduate Diploma, Clinical Research & Pharmacovigilance

Dpm(Diploma In Pharmaceutical Management), Quality Control And Assurance

12Th Cbse, Physics, Chemistry & Mathematics

10Th Icse