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JAIRAJ (JAI) MEHTA
SYNOPSIS OF EXPERTISE AND EXPERIENCE
SUMMARY

Mr. Jai Mehta returned to JM Pharma, LLC, the consulting company in 2005 that he started in 1996, after leaving the management of Red River Pharma LLC, a development and manufacturing company he co-founded. He has been in the pharmaceutical industry for more than thirty (30) years. He has had a successful consulting business and has held senior management positions at various pharmaceutical manufacturing firms. His responsibilities have included R&D, Clinical Research and Regulatory functions, with oversight of Quality and Validation disciplines as well. Mr. Mehta has filed and received numerous Drug (ANDA, IND and NDA) approvals from the FDA during his career in the industry. Containment and separate facility requirements for beta-lactams and highly potent products have been a recent area of Mr. Mehta’s focus and expertise.

Mr. Mehta has audited Active Pharmaceutical Ingredient (API), dosage form, repackaging, and clinical research facilities in US and around the world for compliance to FDA’s quality and compliance standards. Mr. Mehta’s expertise encompasses product development, quality systems validation for bulk drugs and dosage forms (including sterile products such as freeze-dried products, suspensions, solutions, semi solids, powders, oral solid immediate release and modified release products, and metered dose inhalers). Over the last six (6) years, Mr. Mehta has been consulting on projects that include APIs and formulations (topicals, oral solids, as well as parenterals) manufacturing units. Some of the projects included audits, as well as long term assignments for facility design, and complete regulatory and quality systems development in the US, India and Europe.

During Mr. Mehta’s recent consulting work, one of the new facility projects (2007-2009) in Europe has been for a beta-lactam injectable products manufacture. During 2009, Mr. Mehta developed a new and improved Validation Master Plan for all manufacturing processes for one of the largest US topicals manufacturing company. Mr Mehta has written project reports in 2010 for two Indian companies detailing the complete design and budgeting for new green field projects to build facilities for injectable and ophthalmic manufacturing plants. Mr. Mehta assisted a biological toxin product development company in the US in 2010-11 to develop the validation design space by data mining from clinical lots followed by writing an engineering study validation protocol and developing a process validation master plan. Most recently he has led a team of consultants to revalidate all the filling and packaging lines for the largest generic topicals manufacturer in US.

Mr. Mehta was the chair (2010-2011) of the Nutraceutical and Natural Products Focus Group of AAPS (American Association of Pharmaceutical Scientists). He has been actively engaged in other AAPS, ISPE, PQRI and DIA trade associations in developing guidances. Mr. Mehta has given several presentations in the US, Europe and India on the topics of stability, API GMPs, CRO Audits, Labeling v Stability, ICH, Validations, etc

Mr. Mehta has a Bachelor’s degree in Pharmacy and a Master’s degree in Medicinal Chemistry from Bombay University and a Master’s degree in Biopharmaceutics from the University of Illinois. He is a registered pharmacist in the states of Arizona and Illinois.

PHARMACEUTICAL INDUSTRY EXPERIENCE SUMMARY
EMPLOYMENT: JM PHARMA LLC – PHARMACEUTICAL CONSULTING COMPANY
Peoria, Arizona
PART TIME – 1996 – 1998
FULL TIME – 1998 – 2002
FULL TIME 2005 – PRESENT

Founder and President

JM Pharma provides technical and regulatory consulting to the pharmaceutical industry for the manufacturers of dosage forms, bulk drugs and clinical research labs. The areas of consulting include validation, regulatory submissions, quality systems, facility audits, product specifications, process upgrades, product development, Phase I – IV and BA/BE clinical research, and batch certification for clients under FDA Consent decree.

Experience as a consultant:

Facility design, and complete quality, and regulatory systems, infrastructure development and improvement for manufacturing plants for APIs, oral solids, topicals, injectables and ophthalmics for regular, oncologics and betalactam type products in US, Europe and India

Validation/Qualification for manufacturing and packaging processes, equipment and facilities for API and dosage forms [including topicals, solid oral, metered-dose inhalers, topicals and parenteral (ophthalmic and injectables)]. The types of products included regular small molecule pharmaceuticals, antibiotics to include beta lactams, and potent compounds like oncologics and biological toxin.

Validation/Qualification for manufacturing and packaging processes, equipment and facilities for API and dosage forms [including topicals, solid oral, metered-dose inhalers, topicals and parenteral (ophthalmic and injectables)]. The types of products included regular small molecule pharmaceuticals, antibiotics to include beta lactams, and potent compounds like oncologics and biological toxin.

ANDA Validity Assessment auditing to include reconciliation of factual processes and practices comparing against the data and documents in the regulatory submissions.

Regulatory submissions such as DMFs, ANDAs, INDs, NDAs, and interacting with FDA for approval as well as compliance issues

Alliance and joint venture development and management – developed umbrella projects where API and Formulation development and manufacture, along with clinical research were done under one project, including the ANDA filings

Presented training and educational seminars – day long workshops and presentations at own sponsored workshops, AAPS, NAPM, CBI, and DIA. Etc. sponsored events.

Outsource and manage product development and clinical research

EMPLOYMENT:  RED RIVER PHARMA
2002-2005
Shreveport, Louisiana

President, Co-Founder, and Part Owner

Single handedly built as a green-field project, a development, testing and manufacturing company for oral solids in partnership with marketing company, Pamlab, LLC. This 20,000 Sq. Ft. manufacturing and packaging facility along with a 4,000 Sq. Ft. laboratory was developed and built over an eighteen month period, with a capacity to produce 500 million tablets annually.

Experiences and Responsibilities at Red River Pharma:

Established development and quality control laboratory, and also quality and regulatory systems

Designed, procured, and validated facilities, process and equipment for oral solids manufacturing and packaging.

Developed the infrastructure, and hired key employees including head of manufacturing, quality assurance, quality control, regulatory affairs, formulation, process and analytical development, human resources, and information technology staff totaling over 35 employees.Worked with local non-profit organizations, and Universities to develop educational and research programs, and took part in developing University research into viable business products as a member of advisory committees.

Successfully developed, validated and launched four new products in first year of commercialization.

Red River Pharma broke even at the end of its first full year of existence, and was well on its way to be a profitable company.

EMPLOYMENT:  SIDMAK LABORATORIES, INC.
1997 – 2000
East Hanover, New Jersey

Vice President, Regulatory Affairs

Mr. Mehta was responsible for compliance, submissions and other interactions with FDA on behalf of the company. Dosage forms included IR and MR solid oral capsules and tablets; metered dose inhalers; Ophthalmics – solutions, suspensions and ointments; and unit blistered dose packages. Jointly responsible for quality systems, process validation, cleaning validation, and clinical research management.

Experiences and Responsibilities at Sidmak:

Mr Mehta reduced the approval times of ANDA’s to below one year by overhauling approaches to specifications, and manufacturing parameters and controls. The format of the submissions was fine-tuned to be as reviewer friendly as possible.

He enhanced the quality consciousness image of the company within the organization, and with the FDA.

Mr. Mehta also established clinical study monitoring programs and enhanced overall clinical research management.

EMPLOYMENT:  AKORN, INC
1991 – 1996
(DBA- Taylor Pharmaceutical), Decatur, Illinois
Vice President, R & D and Regulatory Affairs
1994 – 1996
Director, Research and Development
1991 – 1994

Responsible for product and process development, analytical development, stability, GMP compliance, defending all FDA inspections, all licensing, U.S. and international registration application submissions, process validation and quality systems.

Experiences and Responsibilities at Akorn:

Mr. Mehta developed research and development and regulatory affairs programs from the ground up – building laboratory and office areas, acquisition of instrumentation, hiring staff, etc.

Audited and assisted foreign and domestic bulk drug substance manufacturers for their DMF approval, and FDA inspection

Ophthalmic product and process development, process validation, technology transfer to production and QA/QC departments, analytical methods development and validation, R & D and commercial stability, ANDA, IND and NDA filing, labeling development, GLP maintenance, training and continuing education programs development.

Defended U.S. FDA’s GMP and Pre-Approval Inspections of the sterile ophthalmic and injectables manufacturing facility.

Component sourcing and specifications; bulk drug substance and excipient sourcing and specifications; Developed quality systems including finished product specifications; stability program, annual product review; documentation change control;

Interacted with FDA and participated in scientific and regulatory committees of trade associations like NAPM, GPIA and NPA.

EMPLOYMENT:  STERIS LABORATORIES
1988 – 1991
(Subsidiary of Schein Pharmaceuticals, Inc.)
Phoenix, Arizona
Manager, Research and Development
1990 – 1991
Manager, Sterile Product Development
1988 – 1990

Responsible for all four groups of R & D – Formulation Development, Analytical Development, R & D Products Support Services, and Pharmaceutical Technology.

Experiences and Responsibilities at Steris Laboratories:

Developed generic injectable, ophthalmic and otic products. Presentations included solutions, suspensions, lyophilized products in serum vials, plastic bottles, two compartment vials, and syringes.

Enhanced GLP’s in the R & D laboratory to meet increased scrutiny of the FDA, and introduced standardized approaches to product development.Developed testing methodologies for a metered dose inhaler product in conjunction with the manufacturer of the delivery system.

Improved existing products, especially suspension and freeze-dried products.

Jointly responsible for annual review of all products, the resultant investigations and the corrective actions.

EMPLOYMENT:  LYPHOMED, INC.
1984 – 1988
Melrose Park, Illinois
Section Head, Formulation Development
1986 – 1988
Group Leader, Formulation Development
1985 – 1986
Scientist II, Research and Development
1984 – 1985

Developed formulations and processes for all company facilities for injectable products, including solution, micro emulsion, and lyophilized products.

Experiences and Responsibilities at LyphoMed:

Developed solution and lyophilized injectable generic, orphan and proprietary products.

Developed medical devices working with device manufacturer.

PROFESSIONAL AFFILIATIONS

Mr. Mehta was the chair (2010-2012) of the Nutraceutical and Natural Products Focus Group of AAPS. In addition to AAPS, he is also a member of the Parenteral Drug Association (PDA) and the International Society of Pharmaceutical Engineers (ISPE)

EDUCATION SUMMARY:

M.S. in Pharmacy (Biopharmaceutics), 1984 – University of Illinois

M.S. in Pharmacy (Medicinal Chemistry), 1980 – University of Bombay, India.

Bachelor of Pharmacy, 1977 – University of Bombay, India.

LICENSURE:

Registered Pharmacist in Illinois and Arizona

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