Helping Companies Reach Compliance Goals Since 2005

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Quality Systems

qualityTicalion provides expert quality system deployment and remediation services to companies that need to meet requirements for FDA compliance and ISO registration and specialize in biopharmaceutical, biologic and medical device product development, manufacturing, and clinical trials.

From large- to small-scale projects, our experienced consultants specialize in the development of compliant and value-driven quality systems as well as remediation of quality systems to resolve FDA enforcement actions including Warning Letters, 483s, Consent Decree, and Application Integrity Process actions.

Clients count on our ability to build strong relationships with their management teams while meeting their goals, and to leverage our successful experiences in dealing with the FDA.

Our services include:

  • Integration of international quality standards and US FDA regulations
  • Deployment and remediation of GMP, GLP, GCP, ISO 13485, and ISO 9001 quality systems
  • ITIL Methodology Implementation including implementation of ISO 27000, ISO 20000, ISO 31000 standards
  • Regulated IT Infrastructure and Computerized System Quality Strategies including 21 CFR 11 compliance and validation using GAMP 5 Methodology and FDA’s General Principals of Software Validation
  • Metrics and Measurement
  • Strategic Goal / Functional Process Alignment
  • Biohazard Risk Management, Compliance & Control Strategies
  • Quality Manual, Quality Plan, SOP red-lining/creation, work instruction and procedures development
  • GMP/GCP/GLP/Medical Device Quality System Audits
  • Turn-key quality management system support including system design/commissioning staff provisioning, training and candidate selection to operate and manage new or transitioning quality management systems

We specialize in working with companies that are at risk for FDA enforcement action (483’s, consent decree and application integrity process) to develop appropriate responses and to implement comprehensive Corrective and Preventive Action (CAPA) strategies. Ticalion provides quality system consultants, medical device consultants and quality auditors that are highly experienced and qualified in their areas of specialty. Our project partners are drawn from degreed and certified professionals in the life sciences and quality management disciplines and have a minimum of 5 years experience in their respective specialties.

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.