Assessment
We build compliance and reporting matrices and conduct quality system and compliance audits including Failure Modes Effect Analysis (FMEA). We perform supplier qualification audits, for cause audits, mock pre-approval/pre-registration audits.
Development
We develop and implement quality management systems to comply with FDA requirements for biologics and ISO requirements. We work with the client to identify regulatory and business requirements related to their quality system and identify key resources for system development, implementation and management.
Implementation
We work with client identified resources to implement the Quality Management System strategy. We write quality policy documents such as Quality Plans, Validation Master Plans and Standard Operating Procedures. We write and execute equipment, software, database and computer system validation protocols and will train your staff to understand compliance requirements.
Management
We develop feedback matrices, perform interim reviews (audits) of the client quality system and review customer feedback to ensure that the quality management system is providing adequate documentation and control of processes to meet regulatory and business requirements.
Ticalion performs the contract services of:
- Quality Auditing
- GMP Manufacturing
- Bulk Manufacturing, Fill Finish, and Labeling (including aseptic processes)
- Raw Material Suppliers
- GCP Clinical Trial Management
- IP Release
- Trial Master File
- Clinical Sites
- CRO’s and Laboratories
- Electronic Data Collection and Clinical Database
- Clinical Study Report
- Tables, Listings and Figures
- CDISC Specialist
- Compliance Review of Essential Documents
- HIPAA Compliance
- Mock Pre-Approval Inspection
- ISO Pre-Registration Audit and Gap Analysis
- GMP Manufacturing
- 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.
Ticalion performs consulting services in:
- Quality Management System Analysis, Design/Re-design and Implementation (GMP, GCP, ISO, and QSR)
- Implementation of Quality and Project Management Methodologies
- Business Process Improvement
- Metrics and Measurement
- Strategic Goal / Functional Process Alignment
- Biohazard Risk Management, Compliance & Control Strategies
- Cost of Quality/ROI