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 Expert  107610

Expert in Pharmaceutical Development & Validation

Available for your Consulting and Expert Witness Needs

Pennsylvania (PA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products to market on a worldwide basis.

Expert has significant experience organizing, developing, and submitting process validation protocols and final reports. The reports were prepared to summarize and detail acceptance criteria and the complaince with FDA requirements. Based on his efforts, he has helped successfully launch four new products at two plant sites. PRE-APPROVAL INSPECTION. He was involved in multiple FDA pre-approval inspections at three sites in the US and Puerto Rico. His team developed standard operating procedures, reports, spreadsheets, and all summary documents for successful pre-approval inspections.

Expert has had significant experience in preparing technical dossiers and CMC implementation for registration and filing purposes for worldwide registration. He has developed protocols and methods of evaluating cleaning procedures for adequately assuring compliance with the most current FDA standards. He has prepared satisfactory cleaning procedures for removing drug residues in accordance with FDA and CGMP requirements. He has audited facilities and plants that manufacture the active pharmaceutical ingredient in bulk drug products. He ensures that the substances comply with FDA requirements.

Experienced in designing and evaluating novel oral drug delivery systems, He and his staff have successfully developed and transferred from Europe a once-a-day antihypertensive drug into the US market. He has been also deeply involved in the formulation of other drug agents, including delivery of peptides via the oral route (as opposed to parenteral administration). He was involved with European companies in selecting and evaluating oral delivery of Calcitonin. He has been deeply involved with the design and scale-up of novel drug delivery systems for parenteral administration. One application involved the surfactant solubilization for lipid soluble agents and nanoparticle systems for intravenous use. The evaluation of manufacturing and sterilization processes were critical elements in this work.

Knowledgeable of pharmaceutical development on a global scale, he is involved in the successful development of a worldwide registration plan for fast-track development and market launch. Expert has been heavily involved in the development and introduction into the European market of a nasal spray delivery system for Calcitonin. He was also very active with multi-dose and unit-dose nasal delivery formulations and packaging systems. Quality control procedures were developed for spray content and spray patterns in accordance with FDA expectations. A significant portion of his career has been involved with international efforts to transfer dosage forms from research and development into plant sites. He has transferred analytical and pharmaceutical drugs from USA to Europe and vice versa. He has also worked in Puerto Rico and various European countries on projects related to scale-up and introduction of programs into production phases. The application of good manufacturing procedures and state-of-art technologies was utilized. He has evaluated polymorphs for effects on drug solubility, bioavailability, and product stability.


drug development


drug formulation


pharmaceutical product development


pharmaceutical product formulation


pharmaceutical research and development


pharmaceutical technology


drug dosage form development


aseptic pharmaceutical process validation


Food and Drug Administration validation


drug validation


Food and Drug Administration


cleaning validation


bulk drug


oral drug delivery


drug delivery


parenteral drug delivery


global regulatory procedure


nasal drug delivery


nasal spray


international technology transfer



Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;  Yonkers, New York;  Newark, New Jersey;  Jersey City, New Jersey;  Paterson, New Jersey;  Elizabeth, New Jersey;  Trenton, New Jersey;  Philadelphia, Pennsylvania;  Allentown, Pennsylvania;  and Stamford, Connecticut.

Often requested
with this expert:

Pharmaceutical Product Development and Good Manufacturing...
FDA Compliance, Pharmaceutical New Products, Management...
New Drug Development and Approval
FDA Regulations, GMP/ GLP/ GCP Compliance; IND, NDA, BLA,...

Year   Degree   Subject   Institution  
1973   PhD   Pharmaceutical Sciences   Rutgers University  
1965   MS   Pharmaceutics   Columbia University  
1961   BS   Pharmacy   Brooklyn College of Pharmacy  

Work History:
Years   Employer   Title   Responsibilities

1995 to 2008






Drug development strategies, product development, expert witness, auditing for CGMP compliance, validation and PAI support, clinical manufacturing

1990 to 1994


Wallace Laboratories


Director, Pharm. Development


Formulation development, Process Development, Outsourcing management, Clinical Manufacturing, Validation and, PAI Product Introductions

1981 to 1990


Rorer Group Inc.


Department Director


International Pharmaceutical Development and Coordination Worldwide clinical study development Process Engineering

1987 to 1989


Rorer Group


Department Director


Process and formulation scale-up, Worldwide process introduction, and Production introductions

1984 to 1987


Rorer Group Inc.


Department Director


Development of Pharmaceutical Analytical, microbiological, and quality services ,worldwide

1981 to 1984


Rorer Group Inc.


Section Head


Worldwide process and formulation scale-up and, plant troubleshooting

1977 to 1981


Purdue Frederick


Director. Pharmaceutical Analysis


Management of pharmaceutical analytical development, CMC preparation, and sterile validation efforts

1977 to 1979


Purdue Frederick


Group Leader


Pharmaceutical formulation development, and management of stability laboratory

Career Accomplishments:

Expert is a member of the American Association of Pharmaceutical Scientists, the International Pharmaceutical Excipient Committee, the Regulatory Affairs Professional Society, and the Validation Advisory Committee of the PMA.


Expert received the Squibb Institute's President's Award for Technical Achievement.

Selected Publications and Publishers  
 - Pergamon Press  

Consulting Services:
Recent Client Requests:
  • Expert for consulting on ANDA submission - nasal spray.
  • Pharmaceutical expert for consulting on DPI blister packaging process for PII.
  • Expert in CMC FDA.
  • Expert for consulting on Need on Product Claims.
  • Expert oral dosage pharmaceutical tablet formulation excipient compatibility API degradation pathways phase III trials CMC pharmaceutical formulation development expert for consulting on oral dosage tablet formulation development.
  • Packaging validation expert for consulting on document.
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:
Recent Litigation Client Requests:
  • Expert for consulting on breach of contract case.
  • Expert for consulting on breach of contract case
  • Expert pharmaceutical formulation and stability for loss lititgation.
  • Expert in homogeneous and hetrogeneous testing for patent case involving a taxane direvative.
  • Drug formulation expert for consulting on Amifostine.
  • Pharmaceutical drug development expert for consulting on testimony on behalf of DEA.
  • Pharmaceutical steroid production expert for consulting and 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.

International Experience:
Country / Region   Summary
Italy, Germany, Ireland, Spain, the UK   He has significant experience in technology transfer with on-site visits to EEC countries, particularly Italy, Germany, Ireland, Spain, and the UK.

Language Skills:
Foreign Language  

Additional Skills and Services:
Other Skills and Services

Expert has significant experience in technology transfer with on-site visits to EEC countries, particularly Italy, Germany, Ireland, Spain, and the UK.


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