HARISH ELUVU

• Responsible for the preparation of variation packages for the EU and US markets, and supporting the life cycle management for global markets.
• Responsible for the compilation, review of the MA dossier, change control assessment, and ensuring compliance with regulatory requirements.
• Collaborated with cross-functional teams (CFTs) and Contract Manufacturing Organizations (CMOs) to compile Chemistry, Manufacturing, and Controls (CMC) documentation, justification reports, stability protocols, and regulatory dossiers in compliance with regulatory authorities.
• Handled the queries from health agencies, customers, and internal stakeholders, and liaised with cross-functional teams for requirements to arrange the required documents for queries and post-approval changes, amendments to the approved dossiers.
• Provided regulatory support for Life Cycle Management (LCM) and developed submission strategies across various project stages, including pilot and pivotal BE studies for India, the US, the EU, and APAC.
• Prepared, compiled, and submitted regulatory dossiers for solid oral dosage forms (Modules II and III) in compliance with US FDA guidelines, including 505(j) and ANDA submissions.

• Prepared, compiled, and submitted regulatory dossiers for solid oral dosage forms (Modules II and III) in compliance with EU and US FDA guidelines, including 505(j) and ANDA submissions.
• Supported the clearance of Inactive Ingredient Guide (IIG) requirements for products in the development phase.
• Reviewed regulatory submission documents for both APIs and finished products, covering Specifications, Analytical procedures, Certificates of Analysis (CoAs), Dissolution profiles, Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Stability protocols and commitments, post-approval stability protocols, and Pharmaceutical Development Reports (PDR).

• Responsible for analytical method development activities (Dissolution, Assay, and RS, etc.) and partial validations.
• Responsible for writing analytical technical documents for developed methods, and supporting the team in various development activities.
• Logging and investigations of OOS, OOT, and questionable results.

Instruments.

• HPLC and UPLC.
• UV-Visible Spectrophotometer.
• Dissolution apparatus.
• PSD, XRD, IR, Karl Fischer moisture meter, pH meter, and analytical balance.

• Good knowledge of granulation techniques.
• Actively involved in oral formulation development trials, pre-formulation studies, and drug excipient compatibility studies.
• Good knowledge of product development.

Formulation equipments.

FBP, rapid mixer granulator (RMG), compression machine, roller compactor, blenders and dryers, spheronizer, and extruder.