Services

What sets us apart from other consulting companies is that we’re in the business of making people happy. We accomplish this through exceptional customer service in the work we perform for you. Whether that’s implementing Quality Management Systems, HACCP/HARPC Programs, validating Master Sanitation Programs, Environmental Monitoring Programs, IQ/OQ/PQ for new installation of equipment, or drafting standard operating procedures, our job is not done until you’re happy with the product produced. We commit as much time and resources as necessary to accomplish for our clients. We value quality over quantity.

  • Form 483 responses and Warning Letter responses
  • FDA applications / submissions
  • FDA compliance master plans
  • Compliance Strategy Planning
  • Project Management (including metrics and oversight)
  • Gap Analysis
  • Mock FDA Audits and Inspections
  • SOP Development (Standard Operating Procedure)
  • Website and Labeling Review
  • CAPA (corrective and preventive actions)
  • Training Programs
  • Management Controls
  • Document Controls
  • Change Controls
  • Design Controls
  • Production / Process Controls
  • HACCP
  • Technical support for law firms that specialize in FDA regulations
  • Training on FDA requirements (laws and regulations)