Quality Assurance, Regulatory and Chemical Syntheses Expert Resume
Resume of VEN, Ph.D. Consultant

  • Biotech
  • Pharmaceutical
  • Quality Assurance
  • Quality Control
  • Regulatory

This expert received a Ph.D. in Organic Chemistry from Indiana University in Bloomington, IN.

This expert received an M.A. in Organic Chemistry from Rice University in Houston, TX.

This expert received an M.Sc., in Chemistry from the Indian Institute of Technology in Bombay.

Quality Assurance, Regulatory and Chemical Syntheses Expert Resume

This expert specializes in quality assurance, quality control, regulatory affairs, chemical syntheses/process development and technology transfer for API’s and dosage forms.

This expert offers in-depth knowledge of US-FDA and European regulations, with regulatory expertise in areas including antibiotics, API, excipients, creams and ointments, non-sterile liquids, solid oral dosage form, parenterals, penicillin products, sterile dosage forms, tablets; Combination Products, Nutraceuticals; Audits: Due Diligence, GMP (Pharmaceutical), ISO, Quality System Inspection, FDA, FDA – 483 and Warning Letter Responses / Consent Decree, ISO – 13485, quality assurance, quality control, quality management, quality systems development / implementation, regulatory affairs, regulatory strategy consulting; Submissions: DMF, 510(k), CMC, Combination Products, IDE, IND, NDA, ANDA, PMA, Training; Medical Devices, Implantables

This expert has technical expertise including analytical chemistry, analytical method development, analytical method qualification / validation / verification, and batch record review. Other experience includes chemistry, CMC review, CMC writing, and corrective and preventive action (CAPA). Further experience includes document controls, failure investigations, gap analysis, and medical devices. Other related fields of experience include laboratory controls, out-of-specification (OOS) Investigations, Non-conformance investigations, and Process Validation. This expert is also experienced in root cause analysis, development history report writing, packaging and labeling, project management, development quality programs, and stability programs. Other areas are SOP development, technical writing, validation / analytical / method / cleaning / equipment / process / retrospective, validation master plans, pre-approval preparation and inspection, process optimization, process validation, sterilization – EtO, training-GMP, validation protocol and report writing.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in quality assurance, quality control, regulatory affairs, chemical syntheses/process development, technology transfer, and related expertise to a wide variety of clients.


On Ground Faculty, Major University

Approved to teach courses in Chemistry, Biology, Health and Nutrition, Environmental Science, Clinical and Regulatory submissions.


President, Biotech and Pharmaceutical Consulting firm

Specialized in providing the following services for the pharmaceutical and biotech industry: Compliance audits Monitoring GMP training SOP’s QA/QC support Preparation of DMF (drug master file), ANDA (Abbreviated new drug application) CMC (Chemistry, Manufacturing, and Control) PAI (pre-approval inspection) preparation Stability studies


Manager, Analytical Quality Control, Abbott Vascular, Temecula, CA

Directed and managed the raw materials quality control laboratory. Responsibilities included preparation of PMA documentation for launch of drug eluting stent in EU and USA. Upgraded laboratories capabilities through improved productivity, training and audit preparedness. Developed and established solvent recovery capabilities for manufacturing. Provided advice and support to process development on alternate plan for polymer purification and drug mixing process. Directed and managed the chemical mixing laboratory for all core products.


Manager, Quality Systems, Abbott Vascular, Temecula, CA

Directed and managed the Quality Control, Analytical method development/validation and Stability studies activities in Temecula and Santa Clara facilities. Directed and managed internal audits, OOS’s and CAPA. Responsible for preparation of the CMC documentation for IDE submission and subsequent responses to FDA’s questions.


Pharmaceutical Consultant

Client: Boston Scientific


Associate Director, Quality Assurance and Regulatory Affairs, Pharmaceutics International Inc., Baltimore, MD

Hosted and managed client, EMEA and FDA audits. Provided audit responses for observations of Clients, EMEA and FDA audits. Conducted internal company and Contract laboratories audits for the company. Ensured corrective actions for all audit observations in the organization. Reviewed technology transfer documents. Assisted clients in the preparation of documents for Regulatory submissions (NDA and ANDA). Built and enhanced existing Quality Systems. Provided operational support for all Quality Assurance functions.


Director, Quality Control and Analytical Services, Trigen Laboratories Inc., Salisbury, MD

Directed and managed laboratory activities related to 4 generic dosage forms. Planned, directed and approved analytical methods development/validation of 3 generic dosage forms for ANDA submission. Communicated with the FDA on ANDA issues and submissions. Successfully navigated Quality Control inspection and audit by the FDA. Directed and reviewed stability studies of dosage forms.


Consultant, Sobha Group Companies and ILI Technologies Ltd., Bangalore, India

Served as Principal Consultant in setting up and management of an R & D/Manufacturing facility for herbal/pharmaceutical and other OTC products. Advised the Chairman in Group companies’ activities.


Chief Technical Officer, Strides Arcolab Limited, Bangalore, India

Directed technical activities of the pharmaceutical group companies including Regulatory Affairs, Quality Control, Corporate Quality Assurance, Formulation development and Chemical development. Directed preparation, audit and submission of documents to global Regulatory bodies. Set up Corporate Quality Policy, established plans and implemented cGMP and cGLP systems and procedures. Ensured FDA, ICH and other Regulatory compliance in R & D, Manufacturing (contract and in-house) and vendors. Directed Analytical R & D, QC and QA activities. Planned and implemented Training for QC, QA and Regulatory Affairs. Audited vendors and suppliers for their Quality systems, cGMP and cGLP compliance.


Director, Research and Development, Ranbaxy Laboratories Ltd, Delhi, India

Directed a large group of scientists in a world-class Analytical laboratory – consisting of over 40 HPLC, 8 GC, 1 LC-MS/MS, 500 MHz NMR, CE, analytical robotics and other analyzers. Planned, Directed and Approved analytical methods development and validation. Directed methods development and validation for over 150 HPLC, HPLC-MS, and GC and Chemical methods per year. Communicated with the FDA and other Regulatory agencies as part of ANDA and DMF submissions. Directed and Reviewed Stability studies of drug substances and dosage forms. Authorized and Reviewed Technology transfers to domestic and International companies including Eli Lilly and Watson in the US. Provided consultation towards set up and management of Analytical laboratories in other locations. Directed Isolation, Characterization and Synthesis of Impurities and Degradation products in drug substances. Planned, Authorized and Managed an annual budget of US $ 1.5 million. Developed processes for chiral intermediates and synthetic processes for generic drug substances. Provided support for preparation, audit and submission of documents to the FDA and other global Regulatory bodies of DMF (4-6) and ANDA (6-8) every year. Participated in the FDA site visits and plant audits.

Author of numerous publications on topics related to chemical syntheses / process development.

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