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

Technical Consultant #1393

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.

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.

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