Helping Companies Reach Compliance Goals Since 2005

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About

aboutFounded by Stephanie Skipper in 2005, Ticalion Quality Management Services, LLC is an experienced and trusted consulting services company that specializes in Quality Management System deployment and process improvement for sponsor companies and intermediaries engaged in biopharmaceutical, biologic and medical device product development, manufacturing, and clinical trials.Clients nationwide count on Ticalion for the following expertise:

  • Quality System Design, Implementation & Remediation for FDA and Global Regulatory Compliance and ISO Registration Business Process Improvement
  • Quality Audits
  • Equipment / Process Validation
  • FDA Enforcement Action Responses

If your company needs a standardized and compliant quality management system, or is at risk for FDA enforcement action (483’s, consent decree and application integrity process), we can help.

Our deep knowledge in Quality System Compliance and Process Improvement helps companies improve features, reduce costs, and increase quality – all done within compliance to keep the FDA satisfied and focused one someone other than you.

Ticalion’s experience with and understanding of the FDA allows us to successfully develop appropriate responses to compliance issues and implement comprehensive Corrective and Preventive Action (CAPA) strategies that help move the client forward.

Our quality system consultants, medical device consultants, and quality auditors are highly experienced in their disciplines. They are also familiar with a variety of business models and management styles which means we blend seamlessly with your system and personnel for quick, effective results.

Our turn-key methodology is perfect for start-ups as well as mature companies that are required to meet project-specific quality management system needs. Ticalion provides and manages the personnel, tools, and quality department functions and provides an integrated quality management system that is customized to your compliance needs.

Clients like that we are flexible and can:

  • Take the lead and manage project resources
  • Integrate as team quality representatives
  • Work as temporary team members
  • Manage ad-hoc projects
  • Perform infrequent activities such as auditing, validation, and crisis management

Click here to request more information or call us at (410) 245-7237.

About Ticalion Quality Management Services
Ticalion provides expert quality system deployment and remediation services to meet requirements for FDA compliance and ISO registration.