FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Contracted Management for FDA Regulated Companies

At FDA Compliance Group, through our Contracted Management program, we can provided temporary placements (short term and long term) for positions that impact FDA quality assurance.

Our solution-based program helps address personnel shortages, immediately filling key positions with qualified individuals who have extensive FDA experience. 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 VPs, we will place the right independent contractor in your organization and/or provide specialized contracted services.

Our services are available for all types of FDA-regulated companies and organizations, including: medical devices, pharmaceutical / drugs, dietary supplements, CROs (Contracted Research Organizations), laboratories, and food and tobacco companies.

Senior-Level / Executive Services

  • fill senior-level management positions (such as Manager, Director, and Vice President) in quality and regulatory departments
  • create evolving management structures for start-up, virtual, and existing companies
  • make recommendations for restructuring management
  • interview candidates and select employees for permanent positions
  • implement succession plans for management

Project Management Services

  • redesign quality management systems
  • manage FDA validation process
  • restructure department work flow
  • implement manufacturing change controls
  • oversee review boards
  • assist with RA management succession planning (Regulatory Affairs)

As part of our team of FDA consultants, we have a number of former employees of the FDA, as well as industry experts (including national experts in several program areas).

For more information on our contract management services or to schedule a consultation, please contact us.