Our Services Include:
  • Audits
  • Certifications to ISO standards
  • Registrations with FDA, EU and other International entities
  • Risk Management support
  • Complaint Handling support
  • CAPA support
  • Remediation Support
  • Supplier Quality
  • Training
  • Quality Assurance & Regulatory Affairs outsourcing services
  • Design & Development of Quality Management Systems (QMS)
  • Regulatory submissions
  • 483 responses
  • Warning letters responses
  • And many more!
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E.M.M.A. International Consulting Group appreciates the opportunity to assess your operations and develop a workable plan for meeting your operational goals within FDA regulations.

FDA Compliance Experts.

When our company received a warning letter from FDA we panicked. The consultants of E.M.M.A. International were invaluable in our remediation efforts and addressing our FDA compliance needs. Not only did they help with our response, they helped us identity the gaps that lead to our warning letter and helped us build a strategy that resulted in a world class quality system. Bob, Director of Quality Assurance & Regulatory Affairs
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FDA Consultants

E.M.M.A. International Consultants are focused on improving the overall performance of organizations in the Biotechnology, Pharmaceuticals, Medical Device and all other FDA regulated industries. We start with a thorough assessment of client facilities, operations, and systems to gain a complete understanding of their current state. We address any issues, judgments, violations head on and develop a comprehensive, strategic plan with actions that our clients can implement and maintain immediately. Our team has experience with warning letters and 483 responses, and can help with the appropriate level of response and documentation

Taking Management Consulting to a Whole New Level  E.M.M.A. International- your one stop shop for all of your quality and compliance needs

 

E.M.M.A. International Consulting Group - Healthcare & Life Sciences - 298x96

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Need a Better Solution? Call E.M.M.A. International Consulting Group