Supply Chain Capability
Choose a company whose experience will take you to the next level. Our industry experts and former FDA officials bring a wealth of experience to any project. We provide practical guidance on supply chain, materials management, APIs, controlled shipping, packaging validation, stop-shipment / recall activities, and import issues.
Our Experience With Supply Chain and Product Distribution:
- Warehouse & Distribution Center Audits
- Vendor Qualification and management
- Storage of Retains and Stability Samples
- Quality System (QS) Implementation for Secondary Packaging, Warehouses, & Distribution Centers
- Packaging
- Review of Shipping Studies
- Supply Chain Auditing
- API and Raw Materials Auditing and Qualification
- Product Recalls Including Product Reconciliation and U.S. FDA / Notified Body Communication
- U.S. FDA Import Alerts
- CLASS I, II, III Recalls
- Global Quality Support for Product Storage & Distribution (Including Australia, Japan, China, India, Europe, Canada, South America, USA, etc.)
- Trade agreements and trade updates – we will help you take advantage of updates and changes and help you minimize cost increases.
- Development of shipping and distribution networks for startups.
- Creating standard operating procedures, work instructions, etc to help you follow best practices.