Regulatory & Quality Systems
Trust and performance are the key decision points for companies looking for their outsourcing partner. Quality is essential, as is uncompromised deliverability and repeatability.
- Documentation, labeling, testing and supply chain exposure assessment and management mitigates critical regulatory and compliance issues.
- Outsourcing quality control, certification and testing provides greater assurance in validations and audits.
Regulatory Alignment
- ISO 9001 Certified with Design Control
- ISO 13485 Certified with Design Control
- FDA QSR Compliant Facilities, Processes & Documentation
- FDA registered as a manufacturer of In Vitro Diagnostics & a handler of pharmaceutical intermediates
Quality Management System
- Full Traceability
- Change Control
- FDA Level Document Control
- Environmentally Monitored Production Processes
- Environmentally Controlled Production & Warehouse Facilities
- Method, Product, Process Validation Capabilities
- Corrective & Preventative Action System
- Continual Improvement System
- Non-Animal Origin (NAO) Control
Analytical & Custom Quality Control Specifications
- Multi-compendial Testing
- Material Certification
- Sensitive Analytical Testing
- Chromatography
- ICP
- FTIR
- Titration
- Spectrophotometric Testing
- Bioburden Testing
- Endotoxin Testing
- Custom Functional & Performance Assays
- Material Origin Control
- Full Lot Traceability
- Products Tested & Retained
CONTACT US
Phone
Toll-Free: 800.448.4442
(U.S. & Canada)
Local: 440.349.1199
Technical Support
Toll-free: 800.610.2789
FAX
Local FAX: 440.349.1182
General Information
Customer Service
Website Questions
Technical Support
Mailing Address
AMRESCO LLC
6681 Cochran Road
Solon, OH 44139 USA