Merchant-Taylor International, Inc.

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