MISSION :

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US FDA
MHRA
TGA
EDMF
COS
DOSSIER
CTD FORMAT
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Mission
Deliver
Expertise
Best Service
Knowledge
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Mission

• To focus on consistently delivering the best
  services to our customers, giving them the
  leading edge to push forward the frontiers of
  knowledge.

• Never lose sight of the fact that while our
  services are essential for the execution of
  projects and our attitude and practices necessary
  for the ease and efficiency of your work.

• Develop procedures and standards that facilitate
  the easy transfer of projects from your end and
  ours.

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About Us
Deliver
Expertise
Best Service
Knowledge
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About Us

• A.J.Associates is a Healthcare consultant group
  headed by Dr. Pramod Pandit. His contribution,
  over the last three decades spreads in some of
  the biggest names in the Indian Pharmaceutical
  Industry.
• He has a rare blend of knowledge and expertise
  with that of controlling and directing the entire
  gamut of business in active pharmaceutical
  ingredients.
• He has an enviable track record of building
  cohesive and motivated teams with a single-minded
  focus in achieving the corporations objectives.

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About Us

• Dr. Pramod Pandit has extensive hands-on
  experience in transfer of technology from
  European Countries in Fine Chemicals,
  Intermediates and Bulk Drugs.
• Before embarking on a career in Consulting, he
  was Vice President operations with IPCA
  Laboratories, Mumbai. He was responsible for
  growth of the organization and for all
  techno-commercial activities for bulk active
  pharma-ceuticals.
• He has worked with reputed Pharmaceutical Giants
  in India in various capacities with top positions
  held in most concerns.

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About Us

• All his experience is backed by a solid academic
  profile.
• Obtained his graduation degree in Science from
  Bombay University with Honours.
• Ph.D. from Department of Chemical Technology,
  University of Bombay.
• Completed Management course in Production.
• Obtained training in advanced techniques in Gas
  Chromatography High-Pressure Liquid
  Chromatography from Perkin Elmer, U.S.A.

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Work Experience
Deliver
Expertise
Best Service
Knowledge
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Work Experience

• His main thrust area of interest was
• Development of Processes for New Products from
  Gram To
• Commercial scale.
• Regulatory Affairs.
• Responsible for improving GMP systems in the
  units.
• Responsible in obtaining US FDA, MHRA, TGA and
  WHO approvals of products and sites.
• He developed quality systems as required by
  International Regulatory Authorities.
• He developed working systems for developing
  technical and analytical data for submission to
  International Regulatory Authorities.

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A.J. Associates
Deliver
Expertise
Best Service
Knowledge
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Work Experience

• A.J. Associates commenced operations in 1996.
• The assignments undertaken revolved around
  Regulatory Affairs and approval of products and
  sites by International Regulatory Authorities.
• Offering guidance to technical team to generate
  appropriate data for submission in DMFs and
  dossiers of COS in CTD format and compiling it as
  per required norms.
• Compiling data for European dossiers in CTD
  format for generic formulations as well as Active
  Pharmaceutical Ingredients.

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Work Experience

• Offered Expert Report and Quality Overall Summary
  based on the data submitted to International
  Regulatory Authorities for EDMF and COS even in
  CTD format, which has been well accepted.
• Assisted more than twenty units to submit EDMF
  and COS with 100 success.
• Conducted a detailed assessment report and due
  diligence report of a leading pharmaceutical
  company for a UK based bank interested in
  investing in the same.

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Association With Professional Associations

• Dr. Pramod Pandit has presented technical papers
  on
• Validation Of Water Systems (1997, 1998).
• Published papers during his research in
  International
• Technical Journals (1964 1971).
• Dr Pramod Pandit has served with Indian Drugs
• Manufacturers Association
• Technical Committee (1992 1996).
• Research and Development Committee (1992
  1996).
• Technical Committee for Audit for Excellence
  Awards (1996 till date).

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Core Competence
Deliver
Expertise
Best Service
Knowledge
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Core Competence

• Developing Process for synthesizing molecules of
  Impurities of Bulk Actives.
• Developing analytical methods for impurity
  profile.
• GMP and GLP audit and corrective action support.
• Conducting technical audit of site and products
  as per norms of US FDA, TGA and MHRA.
• Validation of process and equipments as per US
  FDA norms.
• Validation of analytical methods on HPLC and GC
  as per ICH guidelines.

US FDA
MHRA
TGA
EDMF
COS
DOSSIER
CTD FORMAT
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Core Competence

• Compiling and preparation of dossiers for
  submission to Regulatory Authorities.
• Compiling and preparation of EU dossier in CTD
  format.
• Assisting in obtaining Certificate of Suitability
  for European Commission.
• Study and submit Expert Report and Quality
  Overall Summary for Dossiers and Drug Master
  Files to US FDA, MHRA and TGA Regulatory
  Authorities.

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Specialized Services our Expertise

• Registration of sites and products in developing
  countries.
• Regulatory compliance.
• Assistance in formulating Standard Operating
  Procedures for plant.
• Assistance in modifying the layout of the plant
  as per requirement of US FDA, MHRA and TGA.
• Training of technical staff.

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Specialized Services our Expertise

• Organize studies in Bio equivalence and
  Bioavailability of products.
• Sourcing technology and transfer.
• Guide to conduct studies in Stability Studies as
  per norms of Regulatory Bodies.
• Advise on Variations report as required by MHRA.

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Specialized Services our Expertise

• Conduct Due Diligence Audit of Pharmaceutical
  Units for Interested Investors .
• Audit of an reputed Indian Pharmaceutical major
  having a turnover of over USD 1.5 bn, for a
  leading U.K. Based bank. A complete audit and
  assessment report for investment, facilities and
  export potential was conducted. A detailed report
  was submitted to help in investment decision.
• Another such study is being conducted of a
  reputed Indian Pharmaceutical major which is one
  of the top five pharma companies in terms of
  turnover in India.

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Contact Us
Deliver
Expertise
Best Service
Knowledge
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Contact Us
A.J. Associates 12, Hill View, B-1, Deonar Baug,
Deonar, Mumbai 400 088 INDIA Phone
0091-22-25502626 Tele-fax [phone] Cell
Phone [phone] Email dr_pandit12_at_yahoo.c
om
Contact Us
Contact Us
Contact Us