BALVANT P. PANCHOLI, RAC, M.BIRA.

**** ********* ******

BAYSHORE, NEW YORK 11706-2410

TELEPHONE NUMBER: 631-***-**** – HOME

R E S U M E

BACKGROUND SUMMARY:

Thirty-six (36) years of progressive experience working in increasingly responsible positions with major international drug (OTC/Rx) / Biologic, both GENERIC and Brand Name, (including Tablets, Caplets, Capsules, Oral Solutions, Ointment, Cream and Aseptically – Processed Sterile Liquid and Lyophlized) products and Contract Research / Contract Manufacturing Organizations (CRO’s / CMO’s) in the United States, United Kingdom, and India. Project and personnel management experience in the regulatory affairs (IND/NDA/ANDA/BLA/DMF), regulatory compliance (GxP), and QC / QA / Change Control / Label Development / Pre-Approval Inspection operations with a proven ability to communicate with the domestic (US-FDA, CDER/ CBER) and District Offices (General Inspection and Pre-Approval Inspection), DEA / EPA / OSHA / USDA) and international (MHRA / EMA / Health Canada, Russia, China) regulatory agencies.

PROFESSIONAL SKILLS AND ACCOMPLISHMENTS:

1.0 Regulatory (Affairs and Compliance) and Clinical Affairs Operations (As per FDA 21 CFR Parts 50, 54, 56, 58, 312, 314, 600 - 680):

1.1 Development of a global regulatory (both submission and compliance) strategy in consultation with President, Vice President of Business Development, Vice President of Medical Affairs, and Director of Marketing,

1.2 Development, implementation of strategy and tactics, in liaison with the in-house (Manufacturing, R&D, QC/QA/Compliance) and Outside (Vendors, CRO) personnel for collation and review of all items required for collation of data for Chemistry, Manufacturing and Control (CMC) Section of IND/NDA/ANDA/DMF (and now working on the CTD/e-CTD) for pharmaceutical (Drug) and biologic products following all applicable FDA's / EMA's / ICH’s regulations / guidelines,

1.3 Hands-on and through Support Personnel, Organization and review of required support data for preparation and submission of "Quality-Submissions" (IND's / NDA's / BLA’s / ANDA's/DMF’s) to the FDA and "equivalent" submissions (MAA’s) to the international regulatory agencies and their respective amendments/supplements in liaison with the FDA personnel and monitoring (and responding when required) during their review process until final approval,

RESUME OF BALVANT P. PANCHOLI, RAC, M.BIRA, CONTINUED

1.4 Liaison with the FDA Agency personnel to set-up meetings and coordination of multi-disciplinary activities to put together meeting agenda and submission of support documents for items to be discussed at the meetings,

1.5 Attending FDA (CDER/CBER) Meetings for the IND / NDA /BLA and Preparation of Meeting Minutes for the Upper Management,

1.6 Development of Labeling/Promotional Materials for the currently licensed and new products in liaison with the operational, marketing, and clinical personnel and their approval by the FDA personnel,

1.7 Registration of the currently licensed products in China, Hong Kong, Europe, and South America,

1.8 Development and presentation of setting-up of Clinical Research Program to the Upper Management,

1.9 Development of Auditing Operations for Clinical Investigation Centers, CRO’s, Contract Manufacturing Organizations and Contract Testing Organizations to confirm their required compliance with the FDA’s / ICH’s GLP, cGMP and GLP (GxP) regulations (including CAPA Program),

1.10 Development and maintenance of close association with Contract Research Organizations (CRO's) and Contract Manufacturing Organizations, including on-site audits, for outsourcing of pre-clinical /Clinical and manufacturing of clinical batches,

1.11 Review of all adverse drug reaction events during clinical studies (Phase I / II / III) in consultation with on site clinical/medical personnel and clinical investigators and the FDA and international regulatory agency personnel.

1.12 Pre-Inspection Audit of establishments prior to Pre-Approval Inspection / General Inspection by FDA personnel and Establishment’ Response to FDA,,

1.13 Active liaison with FDA-/CDER –Office of Generic Drug Products/District Office personnel during establishment inspections and coordination of post-inspection activities, including preparation and submission to FDA-CBER/District Office of response to observations made on Form FDA 483, and request for Establishment Inspection Reports (EIRs),

1.14 Development, Implementation and Documentation of Tailor-Made SOP and ON-JOB Training Programs for Support Staff Personnel in the Areas of Submission, Pre-clinical / Clinical Studies,

1.15 Development and Documentation of Tracking Systems Submission System for Pre / Post Submission and Post-Approval Phases and Ongoing Notification to the Upper Management and other Scientific and Pre-Clinical / Clinical Personnel, and

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1.16 Initial Research for Initiation of Electronic Submissions Program for FDA-Related Submissions.

2.0 Administrative / Management Operations:

2.1 Hiring of support staff (professional and secretarial) personnel,

2.2 Training, and effective supervision and motivation of support staff personnel,

2.3 Annual performance evaluation of support staff personnel,

2.4 Budgetary control for the personnel and capital expenditure, and

2.5 Presentation of Regulatory Affairs and Compliance Programs to Potential Investors.

PROFESSIONAL EXPERIENCE:

Current Position: Since April 2004

President / Senior Consultant –Regulatory Affairs, Pre-Clinical / Clinical, CMC, QA/QC and Compliance

SNK Global Consulting Services

Bay Shore, New York 11706

Setting-up tailor-made consulting services - Global Regulatory Affairs, Clinical, CMC, FDA Liaison, Pre-clinical, Clinical, Quality (QA/QC), Compliance– cGMP, GLP, GCP/ICH, Change Control, Facility Validation, due diligent, Liaison with US-FDA and other international (MHRA, EMA, Health Canada) regulatory agencies and Documentation Control Systems for Pharmaceutical (Both Generic and Brand Name) and Biopharmaceutical Products.

October 1996 – March 2004

Vice President of QA, QC, Compliance and Regulatory Affairs

Time-Cap Labs, Inc.

Farmingdale, New York 11735

Responsible to President for the staff of thirty-four (34) professional personnel for the regulatory affairs (both compliance and submission), quality assurance, and quality control operations for solid oral dosages, capsules and tablets, both for immediate and sustained release, label development and review, documentation system, FDA / DEA interaction, and direct customer liaison, Drug Products.

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May 1996 to October 1996

Senior Manager, International Regulatory Affairs

Roberts Pharmaceutical Corporation

Eatontown, New Jersey 07724

Responsible to Vice President, Worldwide Regulatory Affairs for the international registration (submission and compliance operations) of drug and biologic products, in liaison with the FDA, brokers/distributors and international regulatory agency personnel.

February 1995 to March 1996

Executive Director, Regulatory Affairs, Quality Assurance, and Quality Control

Graham Chemical Company

Jamaica, New York 11434

Responsible to the General Manager for the regulatory affairs, quality assurance, quality control, validation, and documentation control operations for the GENERIC Drug (parenteral) products and an active interaction with the state and federal agency personnel during "on-site" regulatory inspection and follow-up post-inspectional activities.

March 1994 to January 1995

Director of Regulatory Affairs

Immuno-U.S., Inc.

Rochester, Michigan 48307

Responsible to Vice President, Operations / Responsible Head for direction of multi-disciplinary activities for regulatory submissions of PLA's / ELA's / Amendments / Labeling / Promotional Materials, compliance, documentation control, and validation of manufacturing operations for biologic products, and active liaison with the FDA (CBER / District) and USDA personnel during "on-site" establishment inspections and follow-up post-inspectional activities.

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June 1989 to March 1994

Regulatory Affairs Manager

Melville Biologics Division / New York Blood center, Inc.

Melville, New York 11747

Responsible to Vice President, Scientific Affairs / Responsible Head for managing regulatory affairs and regulatory compliance operations for biologics and device products for both domestic and international markets. Development and implementation of regulatory strategy for new products, regulatory support for the currently-licensed products, "Hands-on" experience to initiate, co-ordinate and complete PLA's / ELA's / 510k applications, training and supervision of support (technical and secretarial) staff, managing of establishment inspections and active liaison with the FDA / CBER and district office personnel.

November 1988 to May 1989

Regulatory Affairs Specialist

Kendall McGraw Pharmaceuticals

Irvine, CA 92718

Responsible for coordinating multi-disciplinary activities for approval of new generic drugs (ANDA's), quality compliance, and FDA approval of the manufacturing facility.

February 1984 to October 1988

Director of Regulatory Compliance

Advance Biofactures Corporation

Lynbrook, New York 11563

Responsible to Executive Vice President for the regulatory compliance and quality assurance functions for drug (NDA) and biological (PLA / ELA) products, and regulatory review of clinical protocols of drug and biological products in human (Phase I through III studies), and an interaction with FDA (CBER / District) personnel.

February 1981 to January 1984

Manager, Microbiological Services

Byk-Gulden (Altana), Inc.

Melville, New York 11747

Responsible for the quality control, quality assurance, and product development functions for drug and device products. In addition, I assisted in the collation, organization, and review of support data for submissions (ANDA's / NDA) to FDA and Liaison with FDA.

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November 1978 to July 1980

Manager, Research and Development

Oxoid Laboratories Limited

Basingstoke, Hampshire, United Kingdom

Responsible for a multi-disciplinary team of fifteen (15) people (8-Microbiology, 3-Chemistry, and 3-Immunology) for improvement of the currently existing and development of new microbiological diagnostic products.

April 1973 to October 1978

Head, Microbiological Section

Department of Microbiology and Cell Biology

Huntingdon Research Center

Huntingdon, Cambridgeshire, United Kingdom

Responsible for planning, supervision, and coordination of multi-disciplinary projects for pre-clinical In-Vitro and In-Vivo studies and clinical studies in human for new drug products, preparation of cGMP training programs for production personnel, documentation, validation protocols, and quality control / quality assurance programs for clients from the drug, device, diagnostics. foods and cosmetic products organizations. In addition, also responsible for project cost estimate and client liaison.

December 1966 to March 1973

Worked as a microbiologist in increasingly responsible positions with Aspro-Nicholas (Schering), Bristol-Myers, and Squibb Corporations in the United Kingdom.

Responsibilities included routine quality control testing for drug, foods and cosmetic products, cGMP training, development of protocols for screening for new / improved anti-microbiological products (Drugs / Sanitizers / Disinfectants), analytical method development, preservative efficacy testing and clinical testing of drug products in human.

July 1963 to September 1966

Worked as a microbiologist in clinical, dairy, and drug (Squibb) organizations in India.

Responsibilities included setting-up tests for diagnosis of microbial diseases, sensitivity tests, routine pathology, dairy hygiene, and quality control testing of drug products, environmental monitoring of production areas, and conducting pilot-scale production of an enzyme, Penicillinase.

RESUME OF BALVANT P. PANCHOLI, RAC, M.BIRA, CONTINUED

PROFESSIONAL AFFILIATIONS:

1.0 Member, Regulatory Affairs Professional Society (RAPS), USA,

2.0 Member, British Institute of Regulatory Affairs, London, United Kingdom,

3.0 Member, European Society of Regulatory Affairs, London, United Kingdom, and

4.0 Member, the Institute of Biology, London, United Kingdom.

EDUCATION:

1.0 B.Sc. Degree, Microbiology and Chemistry, University of Bombay, India (1963),

2.0 M. I. Biol., Chartered Biologist, the Institute of Biology, London, United Kingdom (1975),

3.0 Regulatory Affairs Certified - R.A.C. by Regulatory Affairs Certification Board, USA (1992), and

4.0 M. BIRA, Elected by the Governing Body of the British Institute of Regulatory Affairs (1994).

PERSONAL:

Citizenship: United States of America (1993)

Marital Status: Married (1975)

E-Mail: adhyji@r.postjobfree.com

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PROFESSIONAL ACHIEVEMENTS

CHEMISTRY, MANUFACTURING & CONTROLS (CMC)

As part of the overall Drug / Biologic Development & Regulatory Affairs Program, I have a proven ability to direct Preparation of, from Concept to Completion, Chemistry, Manufacturing & Controls (from hereafter referred to as “CMC”) sections of the European and US submissions in a timely manner. These activities include (but not limited to):

-Development and execution of Global Strategy and Tactics for the Preparation (Hands-on, through support personnel and local and global project management) of the CMC sections,

-Direct the activities of a CMC group (scientists and technical staff) who are responsible for the preparation of chemistry, manufacturing and controls (CMC) documents for the US-FDA and EU submissions,

-Direct the R&D stability group and routine stability reporting (through US-FDA, EMA and ICH Guidelines/Directives),

-Prepare, coordinate and manage the process of assembling and submitting the CMC portion of regulatory documents. This includes documents and information required for US- Submissions (IND /BLA / NDA / ANDA) and MAA’s -EU/MHRA) submissions,

-Serve as the principle representative in interactions with the Drug Regulatory Affairs

group and with the US-FDA and EU (EMA/MHRA) on all CMC matters relating to pharmaceutical (Drug) development projects,

-Develop and maintain a strong working knowledge of US-FDA (CDER) guidelines and EU Directives and the application of these guidelines /directives to the CMC portion of regulatory submissions,

-Coordinate activities and provide guidance for internal functional groups to ensure acceptance and fileability of documents,

-Interact with scientists and technical staff in the Analytical Chemistry and Formulations Development Departments in an informative and collaborative fashion which supports pharmaceutical development,

-Provide oral and written reports as necessary to R & D management on matters relating to CMC activities, and

–Provide benefit/risk assessments to senior management.

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