The company provides global customized quality, training, and consulting services. The consulting services are delivered with project management oversight supported by the company’s quality management system (aligned to ISO 9001 and 13485 standards) to meet the clients’ needs.
GxP Quality Assurance and Quality Compliance
- Development support for strategic and program planning
GxP Quality Assurance and Quality Compliance Operations
- Clinical investigator site
- Vendor
- Internal Process and System
- Clinical Phase 1
- Trial Master File
- Pharmacovigilance
- Computer System
- Laboratory related
- Product Manufacturing
- For Cause and Fraud
- Institutional Review Board
Regulatory Inspection Preparation/Pre-inspection and regulatory inspection hosting facilitation
Training – Classroom and Online Technology Learning
Quality Management System (e.g., technical writing, review of procedural documents, and consulting)
Customized consulting services
Lead Assessor (Certification) and/or technical expert consultation for ISO 9001 (General Business) and ISO 13485 (Medical Devices)
Resources to support Clients’ quality assurance and quality compliance internal needs
