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BALVANT P. PANCHOLI, RAC, M.BIRA.
**** ********* ******
BAYSHORE, NEW YORK 11706-2410
TELEPHONE NUMBER: (631) ***-**** – HOME

RESUME

BACKGROUND SUMMARY:

Thirty-six (36) years of progressive experience working in increasingly responsible positions with
major international Pharmaceutical / Biotechnology (drug/biologic) products and contract
research and contract manufacturing organizations in the United States, United Kingdom, and
India. Project and personnel management experience in the QA, QC, Regulatory Affairs, and
Regulatory Compliance operations with a proven ability to communicate with the domestic (US-
FDA, CDER / CBER / CDRH, DEA / EPA / OSHA / USDA) and international (Health Canada,
Russia, MHRA- / EMA) regulatory agencies.

PROFESSIONAL SKILLS AND ACCOMPLISHMENTS:

1.0 Quality (QC/QA/Compliance) Operations:

Development, Execution and Documentation of a multi plant global
1.1
Quality (QC/QA/Compliance) strategy in consultation with the upper
management and its implementation at all levels of operations for drug
(solid / semi solid, ophthalmic and other parenteral) and biologic products,

1.2 Establishing specifications (alert / action levels) for raw materials, non
chemical components (closure / container), labeling / packaging materials,
and in process / finished products,

1.3 Vendors Qualification Program, including Establishing contacts with
vendors directly and in liaison with material management personnel for
procuring raw materials (chemical/non chemical components), equipment,
and other critical items within the set QC/QA specifications for
manufacturing products with "Quality Built" design,

1.4 Auditing of in house manufacturing and laboratory operations,
vendors, contract manufacturing / contract testing (CROs) facilities for the
compliance of their operations to the FDA's / ICH /ISO 9000 cGMP, GLP,
and GCP regulations guidelines, preparation of audit reports for the upper
management, including outlining deficiencies and recommendation for
corrective actions,

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1.5 Management of QC (Chemistry / Microbiology) laboratory operations,

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

1.6 Development and implementation of stability testing programs for currently
marketed and new bulk and finished products in compliance with the FDA /
ICH stability guidelines,

1.7 Development and implementation of documentation system, including
Master Production and Control Records, Standard Operating Procedures,
Standard Control Procedures, Document Change Control Notice,

1.8 Coordinating and directing multi disciplinary activities for FDA approval of
manufacturing facilities for sterile products, including validation of HVAC /
WFI / Purified Water Systems, Autoclaves, Ovens / Tunnels, Compounding,
Filter Sterilization, Aseptic Fill, and Labeling / Packaging operations,

1.9 Development and Implementation of FDA's cGMP and GLP training
programs for manufacturing and laboratory personnel,

1.10 Development, execution, and documentation of tailor made protocols for
validation (including calibration) of systems (WFI / Purified Water System,
HVAC System, Preservative Challenge System, and Cleaning System),
equipment, manufacturing processes, and analytical methods,

1.11 Development and implementation of product complaint and product recall
operations, and

1.12 Development, Execution, and Documentation of Stability Programs As per
Current FDA / ICH Guideline Documents.

2.0 Regulatory (Affairs and Compliance) and Clinical Affairs Operations:

2.1 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,

Development, implementation of strategy and tactics, in liaison with the in-house
2.2
(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

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(and now working on the CTD) for pharmaceutical (Drug) and biologic products
following all applicable FDA's and EMEA's guidelines,
RESUME OF BALVANT P. PANCHOLI, RAC, M.BIRA., CONTINUED

2.3 Hands-on and through Support Personnel, Organization and review of
required support data for preparation and submission of "Quality-Submissions"
(IND's / NDA's / ANDA's / PLA's / ELA's – BLA’s / 510k) to the FDA and
"equivalent" submissions 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,

2.4 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,

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

2.6 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 (DDMAC) personnel,

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

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

2.9 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
regulations (including CAPA Program),

2.10 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,

2.11 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.

2.12 Pre-Inspection Audit of establishments prior to Pre-Approval Inspection by FDA
personnel,

2.13 Active liaison with FDA-CBER/CDER/District Office personnel during
establishment inspections and coordination of post-inspection activities,
including preparation and submission to FDA-CBER/CDER/District Office of

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response to observations made on Form FDA 483, and request for Establishment
Inspection Reports (EIRs),

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

2.14 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,

2.15 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

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

3.0 Administrative / Management Operations:

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

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

3.3 Annual performance evaluation of support staff personnel,

3.4 Budgetary control for the personnel and capital expenditure, and

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

PROFESSIONAL EXPERIENCE:

Current Position: Since April 2004

Senior Consultant, QA, QC, RA, CMC, Technical Support, FDA Liaison
SNK Consulting Services
Bay Shore, New York 11706

Setting-up tailor-made consulting services - Global Regulatory Affairs, CMC, Pre-
clinical, Clinical, Quality (QA/QC), Compliance– cGMP, GLP, GCP/ICH, Facility Validation,
due diligent, Liaison with US-FDA and other international (Canada, Australia, Europe, Ireland,
South America) regulatory agencies and Documentation Control Systems for Pharmaceutical and
Biopharmaceutical Industries, Drug and Biologic Products.

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

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, Pharmaceutical and Biotechnology Products.

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 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

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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.

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

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

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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.

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

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

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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: ab6iz9@r.postjobfree.com

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

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 and ICH
Guidelines),

-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 /ANDA/BLA/ NDA) and EU/MHRA) submissions,

-Serve as the principle representative in interactions with the Drug Regulatory Affairs
group and with the US-FDA and EU (EMEA/MHRA) on all CMC matters relating to
pharmaceutical (Drug) development projects,

-Develop and maintain a strong working knowledge of US-FDA (CBER/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,

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-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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