Merchant-Taylor International, Inc.

Principals

Bruce Merchant, M.D., Ph.D., Co-Founder and Principal

• Graduate degrees from the University of Chicago
• Formerly Director of the FDA's Immuno-hematology branch (the Center for Biologics Evaluation and Research)
• Formerly Chairman of the FDA's Hybridoma Committee, and FDA spokesperson for monoclonal antibody policies (1980-1984)
• Formerly Director of Medical and Regulatory Affairs for Hybritech, Inc.
• Formerly Vice President of Regulatory Affairs and Clinical Development, for Viagene, Inc.
• Founded Clin/Regs Associates before forming Merchant-Taylor International
• More than 30 years experience as a Researcher at the National Institutes of Health, as an FDA Regulator, as an Industrial Clinical and Regulatory Director and as a Biopharmaceutical Consultant.    

James A. Taylor, Ph.D., Co-Founder and Principal

• Advanced degrees in Biochemistry from Purdue University
• Formerly Corporate Vice President and Chief Regulatory Officer for ImmunoGen, Inc.
• Formerly Vice President of Regulatory Affairs for Carter-Wallace, North American Director of Drug Regulatory Affairs for ICI Pharmaceuticals (now Astra-Zeneca)
• Formerly a Senior Research Scientist and Regulatory Liason Officer for Pfizer, Inc.
• Founded Taylor Associates, a regulatory consulting firm in 1992 before forming Merchant-Taylor International
• Has extensive experience in Pharmaceutical Regulatory Affairs, GMP Compliance, Quality Assurance and Project Management with large and small pharmaceutical companies as well as vendors and contract manufacturers.

MTI provides biotechnology and pharmaceutical companies with seasoned experienced guidance and expert assistance in regulatory and new product development.

MTI can serve as your project leaders, as a respected liason to the FDA, or as skillful authors and editors in the preparation of FDA documents.

MTI can also identify experienced service providers who perform discovery research, manufacturing, or basic toxicological investigations and can manage these relationships.

Our specialized services are tailored to meet your individual needs.

Our diverse product experience includes:

• Drugs; All FDA Drug Rx Divisions
• Biologics including
  • Monoclonals
  • Recombinant Proteins
  • Gene Therapies
  • Somatic Cell Therapy
  • Vaccines
  • Blood Products
• Medical Devices
• Diagnostics

Biomedical Product Development

• Due Diligence Investigations
• Program Analysis
• Facilities Design and Operations Planning

Strategic Planning

• Integrated Clinical/Regulatory Strategies
• Clinical Protocol Development
• Investigator's Brochures
• CRO Selection and Project Management

Regulatory Expertise

• FDA Liaison
• Preparation of FDA Submissions Including 510K, PMA, DMF, IND, BLA, NDA, and Related Supplements
• Report Writing and Editing
• Orphan Drug Applications
• Package Insert Preparation

Quality Programs

• Quality Assurance Operations and Quality Audits
• Compliance Audits
• cGMP Training
• Validation Services
• QC Advisory Support
  • Product Testing
  • Stability Programs
  • Assay Development/Validation