Pharmaceutical Compliance Consultant: FDA Regulations & Submission with Management Experience at Indian Pharmaceutical Companies

Technical Consultant #1393


Expertise

  • Pharmaceutical quality assurance and regulatory affairs.
  • Skilled in Indian pharmaceutical research and development with leadership positions at Ranbaxy Laboratories, Strides Arcolab, Unilever and Ciba Geigy, all in India.
  • Pharmaceutical GLC and GMC compliance audits, QA operations and regulatory submissions.
  • Pharmaceutical quality control for analytical equipment, method development and validation.
  • Synthesis of active pharmaceutical ingredients (API) and API isolation, identification, impurities and degradation products.
  • Skilled in preparation NDA and ANDA regulatory submission.

Experience

Independent Consultant, 2007 - Present

Vascular Graft Company, Manager - Quality Systems, 2004 - 2007

  • Contract auditing of quality systems and analytical laboratories of pharmaceutical/device manufacturers.
  • Preparation of PMA documentation for launch of drug eluting stent in Europe and USA.
  • Developed and established solvent recovery capabilities for manufacturing.
  • Provide advice and support to process development on alternate plan for polymer purification and drug mixing process.
  • Direct and manage the chemical mixing laboratory for all core products.
  • Direct and manage internal audits, OOS's and CAPA.
  • Preparation of the CMC documentation for IDE submission and subsequent responses to FDA's questions.

Pharmaceutics International Inc., Baltimore, MD, 2003 - 2004

  • Associate Director - Quality Assurance and Regulatory Affairs
  • Company specializes in formulation development, Clinical Trial Material (CTM) manufacturing and commercial manufacturing of most solid and semi-solid dosage forms.
  • Hosted and managed client, EMEA and FDA audits, and provide audit responses for observations of such audits.
  • Conduct internal and contract laboratories audits for the company.
  • Responsible to ensure Corrective Actions for all audit observations in the organization.
  • Assisted clients in preparation of documents for regulatory submissions (NDA and ANDA).
  • Built and enhance existing pharmaceutical quality systems and provided operational support for all quality functions.

Trigen Laboratories Inc., Salisbury, MD, 2002 - 2003

  • Director- Quality Control and Analytical Services
  • Generic pharmaceutical company manufacturing solid oral and hard gelatin dosage capsules for US market.
  • Direct and manage laboratory activities related to 4 generic dosage forms.
  • Planned, directed and approved analytical methods development and validation of 3 generic dosage forms for ANDA submission and communicated with FDA on ANDA issues and submissions.
  • Successfully navigated quality control inspection and audit by the FDA in May 2003.
  • Directed and reviewed stability studies of dosage forms.

Sobha Group Companies, Corporate Advisor Bangalore, India, 2000 - 2002

  • Principal consultant in setting up and management of R & D and manufacturing facility for herbal, pharmaceutical and other OTC drug products.

Strides Arcolab Limited, Bangalore, India, Chief Technical Officer, 1998 - 1999

  • Generic pharmaceutical company manufacturing solid orals, parenterals, soft and hard gelatin capsules and liquid oral dosage forms for global markets.
  • Directed technical activities of the pharmaceutical group companies including regulatory affairs, quality control, corporate quality assurance, formulation development and chemical development.
  • Established corporate quality policy, plans and implemented cGMP and cGLP systems and procedures.
  • Ensured FDA, ICH and other Regulatory compliance in R & D, Manufacturing (contract and in-house) and vendors.
  • Directed Analytical R & D, QC and QA activities.
  • Audited vendors and suppliers for their quality systems, cGMP and cGLP compliance.

Ranbaxy Laboratories Limited, New Delhi, India, Director - Research & Development, 1993 - 1998

  • Largest generic company in India. Corresponding dosage forms also manufactured for US and other global markets.
  • Directed large group of scientists in a world-class analytical laboratory consisting of over 40 HPLC, 8 GC, 1 LC-MS/MS, 500 MHz NMR, CE, analytical robotics and other analyzers.
  • Planned, directed and approved analytical methods development and validation, including methods development and validation for over 150 HPLC, HPLC-MS, and GC methods per year.
  • Authorized and reviewed technology transfers to domestic and international companies including Eli Lilly and Watson in the US.
  • Provided consultation for set up and management of analytical laboratories in other locations.
  • Directed isolation, characterization and synthesis of Impurities and degradation products in drug substances.
  • Developed processes for biotransformations, chiral intermediates and synthetic processes for generic drug substances.

Unilever, Bombay, India,Technical Services Manager, 1989 - 1993

  • Planned and directed development and technical customer support for Industrial fabric washing, kitchen hygiene and food and beverage hygiene.
  • Recommended optimized wash processes to industrial customers

Development Manager, Oils & Soaps

  • Developed new and improved existing processes for bleaching, deodorization and upgradation of non-edible oils in soap making.
  • Identified and evaluated suitable newer non-edible and high lauric content oils.

Research Manager

  • Identified and evaluated suitable non-edible oils for the manufacture of performance oleochemicals.
  • Developed processes for the manufacture of high value perfumery chemicals Ambrettolide and Dihydroambrettolide.

Ciba-Geigy, Goa, India, Development Manager 1988 - 1989

  • Responsible for process development and pilot plant studies of pharmaceutical and agrochemical products.
  • Developed a new process for the catalytic reduction and recovery of chemical intermediates.

Honors & Publications

  • Published 6 papers in peer reviewed journals
  • Presented 10 papers in National and International meetings

Education

  • Ph.D., Organic Chemistry, Indiana University, Bloomington, IN
  • M.A., Organic Chemistry, Rice University, Houston, TX

Other

  • The University of Chicago, Chicago, IL, Post-doctoral Research Fellow
  • Indiana University, Bloomington, IN, Research Fellow
  • Rice University, Houston, TX, Research Fellow
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