Venugopalan is an expert in designing the quality management systems at corporate and site level. He possesses prestigious international certifications such as Certified Quality Auditor (CQA by ASQ) and Regulatory Affairs Certificate (RAC by RAPS) in addition to Lean Six Sigma Green Belt. He is experienced in the managing the end-to-end technology transfer projects of Biotechnology Products. He is experienced in various dosage forms including Vaccines/Biologicals, Pharmaceuticals, and ATMPs. He is expert in leading the projects related to implementation of role-based training, simplification and harmonization for the companies with multiple sites and different dosage forms. His key expertise includes:

Manage the remediation projects and independent assessments of the client firms.

Manage the remediation projects and independent assessments of the client firms.

QMS designing from scratch level for new organizations to redesigning for established organizations

NDA/ANDA data review for complex injectables, similarity/comparability for API of biologics origin, and CMC data review of Biologics.

Lead CAPA verification and Effectiveness Checks for the regulatory commitments.

Lead Investigation robustness, capability building, and certification of the team.

Technical and Quality Due Diligence of Biologics (Vaccines/mAbs), API, Formulations, and Injectables.

Provide oversight on Quality Unit functioning comprising of Audits and Compliance, Batch Release, Qualification/validation, Risk assessments, Quality Agreements, APR, Change Controls, Deviations, Investigations, CAPA, Training, Quality Review Meetings, Clinical Quality Assurance, Audits (Vendor, CRO, nonclinical labs, clinical trial sites, etc.).

Provide guidance on preparation of dossiers for CTA & MAA, pharmaceutical data on dosage form, Clinical trial exemption, coordination with the regulatory agency for approval of clinical trial, variation applications, and submission of periodic updates on clinical trial.

GCP compliance auditing which includes System Audits, Trial Site Audits, Central laboratory, Study Management Audits, and Trial Master File Audits for early to late-phase clinical trials spanning across Sites, CROs, Labs, and allied vendors.

Review/verification of development, manufacturing, and testing documentation for ensuring data accuracy, adequacy, completion, and conformance with the MAA requirements, in line with the company’s regulatory strategy

Harmonization and implementation of QMS across multiple manufacturing units, involving procedural change, integration of IT systems, and imparting training across sites.

Design & establishment of phase appropriate Quality Management System/GMP compliance for Biological/Pharmaceutical Products from R&D level to a full GMP compliant level as per national/international guidelines/regulations.