How We Help You

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 in the following:
    • 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.

How We Work

Our philosophy and our methods are different from those of many larger consulting firms.

The difference – we do not imply that you need a large group of consultants who will remain at your locations for extended periods of time. That may be necessary at certain times, such as when recovering from a consent decree. However, many compliance problems are not of that magnitude and can be corrected more readily.

Instead, we send one consultant – sometimes two, depending on the nature of the situation – for a predetermined short period of time, anywhere from days to a week or more, to identify the problem specifically and propose a solution to it.

When we all agree on the nature of the problem and the proposed solution we will present a realistic time frame to completion. Then, upon your approval, we “fix the situation” and bring you into compliance.

This manner of identification and solution has been proven to be the most cost effective for you, our client.