How Cardinal Assists Attorneys and the Pharmaceutical Industry

Subject Matter Expert Consulting

Cardinal can provide you with over 40 years of experience in the pharmaceutical industry, and my services are available internationally. I have successfully assisted attorneys – plaintiff and defense – as a Subject Matter Expert (SME Consultant) in the following areas:

  • Chemistry
    • Test procedures and data evaluation
  • Patent infringement
    • Process
    • Product
  • Pharmaceutical production processes
    • Batch record management
    • Contamination
    • Procedure compliance
  • Product Liability
    • Technical accuracy of labels and claims
    • FDA regulatory compliance
  • Food, Drug, and Cosmetic Act (FD&C Act) labeling regulations
    • Label claims
    • Size and positioning of text
  • Food and Drug Administration Good Manufacturing Practices (GMPs) compliance
    • Pharmaceutical firms
    • Active Pharmaceutical Ingredient (API) producers
    • Contract manufacturers
    • Contract testing laboratories

Pharmaceutical Consulting

Cardinal Consulting and Training provides individuals or teams of experts to help you deliver new products to the marketplace by assisting in Regulatory, Technical, and Management areas such as the following, thereby avoiding regulatory and other delays.

  • Food and Drug Administration Compliance
    • Quality Audits and Implementation of Changes
    • Establish/Review Quality Assurance Procedures and compliance with GMPs, including GLPs
    • Prepare the Chemistry, Manufacturing, and Controls section of a New Drug Application (CMC section of NDA)
    • Prepare Drug Master Files (DMFs)
    • Prepare for Pre-Approval Inspections (PAIs)
    • Process Validation
    • Establish program for Corrective Action/Preventive Action (CAPA) including Root Cause Analysis (RCA)
    • Establish system for Out of Specification (OOS) results and for Deviations
    • Consult/assist in responses to FDA Warning Letters
    • Consult/assist in responses to FDA “483”s

  • Technical
    • Laboratory Procedures — Development and Validation
    • Package/Product Compatibility
    • Selection and Testing of Rubber Stoppers and Plastic and Glass Components
  • Management
    • Laboratory Management
    • Work Flow Design
    • Strategic Planning
    • Establish responsibilities and performance criteria for contractor organizations
    • Establish goals, responsibilities, and performance criteria for departments to eliminate errors and unnecessary redundancies and to ensure maximum efficiency
  • Training — Design and present training programs on the following subjects:
    • CAPA
    • GMPs
    • Leadership skills for new managers
    • Project planning and management to include:
      • Acquisitions
      • Affiliations
      • New facility establishment (site selection to first product shipped or first test conducted)
      • Direct a department and effectively interact with other departments
    • Preparation for an FDA inspection — GMP or Pre-Approval
    • Public Speaking skills for your personnel. All other things being equal, the person who speaks better in public is the more believable.