ORC Expert Advisory Services ORC International

  home    |    find an expert    |    request an expert    |    join our network    |    about us     expert login  
Expert Consulting and Expert Witness Services
  search tips 
Share this page:  Send to LinkedIn Send to Facebook Tweet This Email Print

 Expert  725858

Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management

Available for your Consulting and Expert Witness Needs

Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects, regulatory affairs, quality assurance / process control, general management. He has studied applied organic chemistry at Post graduate and doctorate level and came out with flying colors. He has hands on experience in Aseptic pharmaceutical Process Validation for Sterile Cephalosporins (APIs). He has experience in bulk packing of generics and APIs which involves use of bulk packing materials. He has experience in bulk packing of generics and APIs which involves use of bulk packing materials. He successfully handled contract manufacturing at major strategic partners during his association with Actavis / Alpharma and Kopran.

21 CFR Part 11


Food and Drug Administration regulation


active pharmaceutical ingredient


bulk drug


bulk pharmaceutical chemical manufacturing


contract manufacturing


bulk packaging material


aseptic pharmaceutical process validation


applied organic chemistry

He has successfully applied cGMP during his tenure at Ipca, Ranbaxy, Kopran, Actavis / Alpharma, and plant got approved by various regulatory agencies. He has got experience in the development of various APIs and Dosage forms. He worked with world's top ten generic company and worked on the end to end development of generic drugs ranging from API development, API manufacturing, DMF filing, Dosage form Development, bio batches, ANDA filing, commercial production and product launch. He has worked on the synthesis of heterocyclic compounds during Ph.D. He has hands on experience in nonaseptic process validation during his employment and association with various companies. Organic chemistry was his specialization during M.Sc. and Ph.D. and worked in industries who are involved in manufacturing or organic compounds. He helped the alliance partner in preparing for PAI and company got approved without any 483. Presently assisting the client for PAI.

Current Good Manufacturing Practice


Food and Drug Administration compliance


Good Manufacturing Practice


drug development


generic drug


generic drug manufacturing


heterocyclic compound synthesis


nonaseptic pharmaceutical process validation


organic chemistry


synthetic organic chemistry


pre-approval inspection

Show Secondary and Basic Areas of Expertise

Year   Degree   Subject   Institution   Honors
1982   Ph.D   Synthetic Organic Chemistry   National Chemical Laboratory, Pune, India  
1978   M.Sc.   Organic Chemistry (Drugs)   Vikram University, Ujjain, India   1st Rank in Univ
1976   B.Sc.   Chemistry, Botany, Zoology   Vikram University, Ujjain, India  
1987   P.G.Diploma in Production Management   Production management, marketing, finance mgt.   Marathwada Univerity, Aurangabad, India   1st Rank in Univ

Work History:
Years   Employer   Department   Title   Responsibilities

2008 to




Regulatory Affairs




He works with clients in the pharmaceutical industries to develop quality assurance and regulatory strategies for compliance with US FDA and European regulations by:

• Conducting assessments of client studies, procedures, and programs to determine compliance. • Development and adherence to Quality Systems; • Development and control of various documents. • GMP for process and facility; • Validation with respect to, -Validation Master Plan (VMP) drafting, incl.facilities, utilities, equipments, process & analytical methods; -Generating of validation protocols and reports; - Validation training; - Execution of DQ, IQ, OQ & PQs ; • cGMP and GLP compliance with .respect to, - Auditing (self-inspections and suppliers); - Preparing for inspections and pre-approval inspections; - Sterile and aseptic production techniques; - Documentation control and support and Standard Operating Procedures (SOPs).

2005 to 2007


Actavis Group / Alpharma Inc.


Alliance Management


Technical Director (Asia)


He managed Human Pharmaceuticals Div. development programs and initiatives including product Research & Development, Technical Services organization projects, Business Development due diligence support and Scientific Affairs Regulatory Compliance activities performed through one or more partner companies in the Asian Sector. • He proactively managed cross-functional teams between parent and partner organizations to include the areas of Research & Development, Technical Services, Manufacturing, Operations, Quality, Regulatory, Marketing, Intellectual Property and Legal to ensure that Scientific Affairs objectives including completing ANDA and MA filings and launching new products are achieved in a timely and GMP compliant manner. • He proactively managed cross-functional teams of technical and non-technical personnel to assure efficient technical transfer of new products/processes to commercial operations and to prepare the organization for FDA and European regulatory authority pre-approval inspection (PAI) audits.

2000 to 2005


Kopran Limited, Mumbai, India


Profit center -API


Vice President - Technical


- He functioned as a change agent in evaluating all operations, developing / implementing sound manufacturing strategies to optimize resources and equipments while ensuring product quality and timely delivery. - He defined and recommended mfg. objectives, develop specific short-term and long-range plans and program together with supporting budget requests and financial estimates. - He continually and aggressively reduced the business unit's cost position. He optimized production while driving efficiency. - He identified and prioritized opportunities to improve overall gross margins. - He directed, reviewed and approved the development of objectives, policies and programs for operations activities involving sourcing, supply chain mgt., quality, manufacturing, mfg, engineering, projects, regulatory affairs and process development. - He provided leadership on production-related procurement by developing strategies and objectives along with the strategic sourcing team to identify and develop high-quality, low-cost suppliers on a worldwide basis. - He was actively involved in promoting key strategic alliance partnerships, new business development, joint ventures and technology transfers at an international level.

1996 to 1999


Ranbaxy Laboratories Limited, Dewas, India


Unit Head -API


General Manager - Manufacturing


His overall responsibility was for API manufacturing at site.

1993 to 1995


Ipca Laboratories Ltd., Indore, India


Profit centre- API


General Manager


He had multi locational responsibility manufacturing API and APIs intermediates.

1990 to 1993


Stellar Chemical Laboratory, Derol, India


Profit Center - API


Works Manager


He set up R & D Center, Pilot Plant and commercial plant and managing commercial production of APIs.

1989 to 1990


Jayant Vitamins Ltd., Ratlam, India


Process Control / R & D


Manager - Process Control


He managed the Process Control and R & D departments

1988 to 1989


Nicholas Laboratories India Ltd., Mumbai, india




Manager - Bulk Drugs


He set up API division which includes setting up of R & D Center, pilot plant and commercial plant for the manufacture of APIs.

Career Accomplishments:

He is a Member, Indian Institute of Management, Ahmedabad and Administrative Staff College of India Alumni Association.

Professional Appointments

He has been: Secretary, Chemical Association during M.Sc. and Secretary, Student Union during B.Sc.


• Significant Performance Award by Wockhardt and helped the company in winning Award for R & D Efforts in Industry of Govt. of India. • Merit and National Scholarships, Junior & Senior Research Fellowship of CSIR., Govt. Of India • N.C.C. ‘B' Certificate.

Publications and Patents Summary

He published three papers in international and national journals during Ph.D and published one Us and one India patent.

Selected Publications and Publishers  
 - Chemistry and Industry  
 - Annual Convention of Chemists  
 - Journal of the Chemical Society - Chemical Communications  
 - U.S. Patent and Trademark Office  
 - Indian patent  

Consulting Services:
Selected Consulting Examples:
  • He provided regulatory consultancy to one of the client for the preparation of US FDA Pre Approval Inspection. This is an extensive green field project which includes creation of Quality Management System, helping the client in compilation of Dossier, Process Validation, and Cleaning Validation and conducting mock PAI.
  • He audited API manufacturing facility to ascertain client's preparation for inspection and suggested the ways to correct the gaps.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
English   very profiecient

Market Research:
He has expertise in various facets of Pharmaceutical industry ranging from general mgt, Operations, R & D, projects, process control, regulatory affairs, business development & partnership management.Areas of expertise include the following: MANUFACTURING / OPERATIONS ? Cost Reduction – Quickly analyze variable and fixed operating costs and reduce spend ? Restructuring/turnaround management – Optimize operations, consolidate, outsource and reduce costs ? Performance Improvement – Lean efficiency transformations, best practices, employee involvement and sustainable results ? Interim Management – Immediately step into a key operations or manufacturing role and hit the ground running, provide expertise, leadership, teamwork and stability ? Improving capacity & through-put ? Multi location operations. ? Team building ? Handling of cross-functional teams ? Manufacturing of Sterile API

PROJECTS ? End-to End Development Projects ? Facility Designs ? Partnership Management ? Capacity expansion ? Quality & Research Laboratory Design ? Quality & Research Laboratory Design ? Improving capacity & through-put


? Quality System Development & Implementation ? Internal GMP Audits ? SOP Preparation ? Analytical Laboratory Audit ? Audit of CROs (Clinical). ? Audit of Vendors / Suppliers ? Audit of Research Laboratories


? Process Start-ups, Scale-Up & Commercialization ? Process Optimization ? Process Reengineering ? CMC Documentation ? Technology Transfer


? Preparation of Validation Protocols & Master Plans ? Protocol Implementation ? IQ, OQ and PQ of Systems ? Process Validation ? Cleaning Validation ? Analytical Methods Validation ? Utility Validation

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

He delivered various seminars and imparted training to employees at Ipca Labs, Ranbaxy Labs, Actavis partner companies and Marion Weinreb & Associates clients on the following ? GMP Basics ? Regulatory compliance ? In- house Seminars. ? Training Modules preparation

Supplier and Vendor Location and Selection

He has hands on experieence in developing strategic alliance partnerships, auditing various facilities for future tie-ups, auditing Clinical Research Organizations and Research Centers, technical due deligence. Developed long term contracts for supply of key raw materials

Other Skills and Services

He is a turnaround expert in pharmaceutical industry specifically API industry.


Need the right expert?  We can help!

home       find an expert       request an expert       join our network       about us

Intota is now ORC Expert Advisory Services