Cardinal Consulting and Training

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 GMP's, including GLP's
- Prepare the Chemistry, Manufacturing and Controls section of a New Drug Application (CMC section of NDA)
- Prepare Drug Master Files
- Prepare for Pre-Approval Inspections (PAI's)
- Process Validation

• Technical
  
- Laboratory Procedures - Development and Validation
- Package/Product Compatibility - Selection and Testing of Rubber Stoppers and Plastic and Glass Components
- Lyophilization — Various aspects

• Management
  
- Laboratory Management
- Work Flow Design
- Strategic Planning

Click here to see a partial list of the projects that we have worked on.

Click here for the Professional Background of James J. Farley, Principal.

Our experience in the pharmaceutical industry and with the Food and Drug Administration includes both sides of the regulatory hurdle, and as such, we are in a position to counsel others on cost efficient ways of surmounting that hurdle.

How can we help you?

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