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Madhu Sundar

Partner

About Madhu Sundar


Madhu Sundar is a Senior Consultant and Partner at QualiCulture Consulting Group Consultants who has over 20 years of experience in the pharmaceutical industry. He is an expert in operations management, compliance and regulatory practices. He has an extensive regulatory affairs and quality assurance background to interpret and apply cGMP regulations relating to a broad range of products and processes. He is instrumental in providing the direction and management of pre-approval and pre-license inspections and compliance evaluations for DMFs, ANDAs and NDAs of solid dosage / API manufacturing plants.

EXPERTISE:

  • Quality / Regulatory Affairs Specialist
  • Enhanced Drug Master File Submission rates to over a hundred submissions in the US and close to a 100 CEP approvals in his leadership at Aurobindo Pharma Ltd.
  • Lead the largest green field project of solid dosage manufacturing (2.5 billion dosage units) and commercialized in 18 months with successful regulatory approval.
  • Preparation for preapproval inspections and audits
  • Assist in the development of responses to regulatory findings 
  • Perform GMP, Compliance and Quality Systems audits and CAPA management
  • Deliver Quality, Compliance, and Regulatory training
  • Perform technical writing (protocols, reports, specifications, policies, procedures)
  • Perform due diligence audits for new and commercial products (CMC-related issues)
  • Conduct detailed record reviews for consistency and adequacy
  • Review / prepare INDs, NDAs, ANDAs, DMFs  (submissions, amendments, supplements, and annual reports)
  • Review applications and associated documents for determining the completeness, accuracy and conformance to regulations and commitments
  • Prepare site registration and drug listings
  • Manage and perform audits of process validation, stability, OOS investigations, change control, training programs, contract manufacturing, ingredient supply chain controls, SOP and documentation practices, management controls
  • Review process improvement initiatives and Develop continuous improvement plans including quality management systems
  • Lead lean management and operational excellence projects to enhance the productivity

EXPERIENCE:

  • Site Head and Product Supply at Apotex Research Pvt Ltd.
  • Vice President - Head of Operations at Aurobindo Pharma Ltd.
  • Vice President - Corporate Quality Assurance and regulatory Affairs at  Aurobindo Pharma Ltd.
  • Various Roles in Quality Management, Technology Transfer and Supply Chain Management at Ranbaxy Laboratories Ltd.

EDUCATION:

  • Master of Science in Chemistry 
  • Master of Technology in Chemistry and Technology 
  • Masters in Technology (Modern Methods of Chemical Analysis)  a course in Advanced Analytical Chemistry with Industrial applications


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