Contracted Management for FDA Regulated Companies

FDA Compliance Group offers contracted management services for FDA regulated companies that need interim quality and regulatory leadership. Through our Contracted Management program, we provide temporary placements, short term or long term, for positions that directly impact FDA quality assurance.

We help you address personnel shortages quickly by placing qualified professionals who have extensive FDA and industry experience in your key positions. We can provide contract workers at all levels, for any length of time, to assist you with your project needs and keep your firm moving in the right direction. From project managers to vice presidents, we will provide the right independent contractors and specialized contracted services for your organization.

Our contracted management services are available for medical device manufacturers, pharmaceutical and OTC drug companies, dietary supplement brands, CROs (Contracted Research Organizations), laboratories, food & beverage companies and tobacco companies.

Senior Level and Executive Services

Our FDA Contracted Management team can help you:

  • Fill senior-level management positions in quality and regulatory departments, including Manager, Quality Management Rep, Director, and Vice President
  • Create evolving management structures for start-up, virtual, and established companies
  • Recommend restructuring options for quality and regulatory leadership
  • Interview candidates and help select employees for permanent positions
  • Implement succession plans for management
  • Project management services

Our contracted managers and consultants can:

  • Run quality and regulatory departments
  • Redesign quality management systems
  • Update SOPs and forms to meet current requirements
  • Manage FDA validation process
  • Restructure department work flow
  • Implement manufacturing change controls
  • Oversee review boards
  • Conduct management reviews
  • Managed complaints, trending and CAPA
  • Lead MoCRA and FSVP development
  • Assist with Regulatory Affairs (RA) management succession planning

Our team includes former FDA employees and recognized national industry experts in multiple program areas.

For more information about our contracted management services, or to schedule a consultation, please contact us at (303) 903-4801.

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