Bharathi Kodali

About Bharathi Kodali

Who am I? I am a University Gold Medalist, Regulatory Strategist and Intelligence/CMC Expert/QMS Expert Professional offering about 16 years of experience in Regulatory Submission/Strategies/Filing/Affairs, CMC Regulatory Affairs, NDA, CAPA, ANDA, Project & Product Management, Clinical Trials, Clinical Research, Quality Investigation, Audits, Deviation/Change/Quality/Escalation Management, Site Transfer, Continuous Improvement, Business & Product Development, Team Leadership & Management, and so forth. Significant Projects & Accomplishments First launch of NRT (Nicotine Replacement Therapy) – lozenge and chewing gum in India Filed Oral Contraceptives (35 ANDAs) and got approved without any deficiency Filed First-to-File ANDAs (40 ANDAs) without any RTRs Received Day 0 approval for all Final Request Amendments filed (Tentative approval to Approvals without any query) PEPFAR (President’s Emergency Plan for AIDS Relief) ANDAs/NDAs Combination Products and 505 (b)(2)s Filed variations to harmonize a single formulation across the globe Justified the change in coating variation with retrospective batches across the globe Provided comments for many FDA Draft Guidelines which were further considered for reiteration, explained in the next/final version Received appreciation many a time from FDA Reviewers that the cover letter is well explained and initial ANDA submissions were crystal clear I have developed a digital tool to monitor depression in cancer patients, and I have conducted research in cancer therapies using various innovative approaches. I am well-versed in data sciences and artificial intelligence tools. I am passionate about volunteering and supporting cancer research, and I am motivated by the mission of improving patient outcomes and access to affordable medicines.

Experience

1. Regulatory Compliance Manager

   Sandoz

   Oct 2023 — Present · Hyderabad, IN

   Regulatory Strategy Ensuring compliance and comprehending how changes may impact the products (under development, under review, tentative approved and approved products) by navigating the intricate and ever-changing world of USFDA regulations (Nitrosamines, Elemental impurities, CGT, shortages, import alerts of Bio and API sites used in the ANDAs) Contributing to the team that researches consumer preferences, competitor product offerings, and market trends to assist the company in creating new and profitable marketing strategies Regulatory Submissions Pre-submission Phase: In charge of submitting controlled correspondences for Q1 and Q2 injectables, excipient quantities (IID), evaluating bio recommendations and dissolution, deciding on citizen and suitability petitions, running the CGT, monitoring drug shortages, fully evaluating drug substance, providing DMFs for excipients not included in official monographs, and self-evaluating facilities (analytical, clinical, etc.) Submission and Query Phase: Demonstrated ability to handle administrative, post-approval, and initial submission queries with logical and scientific justifications to expedite fast-track approvals Creating modules 1 - 5 for new submissions (Regulated Markets) and second wave submissions (Extension of Dossiers to rest of the world) Post-Approval Activities: Accountable for change evaluation and providing regulatory input for worldwide regulatory impact Evaluating and submitting post-approval supplements Contributing expert regulatory insight to strategic decision-making and leveraging experience in risk assessment and gap analysis for registered CMC procedures and information at manufacturing facilities Working on international projects, handling everything from the initial contract to tech transfers, site transfers, MAH transfers, filing modifications, and commercialization to ensure business continuity

Education

• Annamalai University

  Master of Pharmacy

  2005 — 2007

• Sri Padmavati Mahila Visvavidyalayam

  Bachelor of Pharmacy

  2001 — 2004