Our Mission
Our mission is to become your partner in ensuring the success of your business. Effective quality assurance and quality control identifies and controls variability that contributes to inefficiency and waste. Minimizing inefficiency and maximizing customer satisfaction are the keys to a profitable business. Compliance to federal, state and local laws and industry standards is important but practically speaking, quality assurance is good business sense that offers the tangible benefits of repeat business and increased profitability.
Our Vision
Our vision is informed and effective management solutions through quality system design and program management.
Our Goal
Our goal is to help you;
Realize Business Potential
About Us
Ticalion Quality Management Services, LLC is a consulting services company that performs Business Process Improvement and Quality Assurance consulting and auditing for government agencies, government contractors, sponsor companies and intermediaries engaged in biopharmaceutical development (R&D), manufacturing (GMP) and clinical trials (GCP).
We work best with dynamic small to mid sized enterprises. Our technical expertise includes:
- Quality System Design, Implementation and Remediation for FDA global regulatory compliance including GCP, GMP and Medical Device
- Business Process Improvement, Metrics and Cost of Quality
- Quality Management Systems for ISO Registration.
- Equipment, Process and Computerized System Validation.
We stay abreast of emerging industry developments by performing auditing, validation, and process-related work that spans the biopharmaceutical development arena from sponsor-level decision making to clinical trial site best practices. We are experts at discovering practical solutions to real world business initiatives.
We specialize in working with clinical trial sites, contract research organizations and sponsor companies that are at risk for FDA enforcement action (483′s, warning letters, consent decree, and application integrity process) to develop appropriate responses and to implement comprehensive Corrective and Preventive Action (CAPA) strategies.
About Our Managing Director and Senior Consultant
Stephanie Skipper is an accomplished quality management professional with over 10 years experience in biotechnology quality assurance and over 13 years project management experience involving complex technical projects. She holds the following accreditations and professional certifications:
- Master of Science, Quality Assurance/Regulatory Affairs – Temple University School of Pharmacy
- MBA Foundations – Temple University Fox School of Business
- Bachelor of Arts, English with Biology minor – Temple University
- Certified Manager of Quality/Organizational Excellence (CMQ/OE) – American Society for Quality
- Certified Quality Auditor (CQA) – American Society for Quality
- Clinical Trial Management Certification – Temple University School of Pharmacy
- Project Management Professional (PMP) – Project Management Institute
- download full pdf resume