CERICON is a consulting company that specializes in building strong Quality and Regulatory Systems in FDA-regulated industries with a focus on medical devices.
We fulfill our mission through:
- Systems Solutions - We believe in an organizational and systems approach to developing, building, and sustaining strong Quality and Regulatory Systems.
- Leadership and Teamwork - We work with you to solve problems and develop innovative, robust solutions. We partner with your key personnel to GET RESULTS! We develop your staff to continue the work.
- Knowledge - We have the business, management, quality system and regulatory knowledge to help you solve problems and develop lasting solutions.
- Integrity - We are committed to conducting our business with strong commitment and high integrity.
The CERICON network is staffed by professionals who have "done the work". Our hands-on knowledge and experience covers a broad range of business, management, Quality System and regulatory issues/situations.
We offer the following services.
- Resolution of FDA issues and enforcement actions including FDA Form 483s, Warning Letters and Consent Decrees.
- Quality Systems remediation and development including system design, gap assessments, training and audits (Quality System Regulation (QSR), cGMP, ISO 13485, MDD, AIMD, CE Marking and other national and international standards)
- Regulatory compliance to FDA Title 21 regulations including Quality System Regulation (QSR), Registration, Listings, recalls, Corrections and Removals, crisis management, adverse event reporting (MDR), and submissions.
- Management and Business Process Improvement including financial health, defect elimination, continuous improvement, strategic management and teamwork development.
- Contract Management to temporarily fill key roles in your Quality Assurance or Regulatory organizations.