CDx Manufacturing

Almac Diagnostics Services’ Manufacturing Team has experience in the manufacture of ssPMA lab developed tests and IVD kits. The team regularly engage with the FDA to support pre-submissions, conduct process validation studies, and prepare manufacturing processes for PMA submissions. In addition, the team also provide support to obtain IDE approvals and are instrumental in supporting CE-marking of Clinical Trial Assays.

Almac CDx Manufacturing Capabilities

Packaging and Design

• Bespoke packaging & label design service managed by a specialist team
• Labels design to comply with 21CFR 801/809 and ISO15223
• Label material validation
• Technical consultation for component selection
• Inventory and temperature-controlled solutions for stock

Reagent Preparation

• Dedicated suite for the preparation of reagents and control samples
• Environmentally monitored facilities
• Robust QC procedures

Quality Control

• Development and validation of QC test methods
• Validation of the Manufacturing Process
• Dedicated equipment lines
• Sampling and component testing
• Manufacturing process surveillance

Kit Production

• Set up and assembly of dedicated production lines for a range of IVD kits and batch sizes
• Inventory management system for stock monitoring
• Temperature controlled facilities and warehouse
• Controlled production processes and robust staff training

Logistics and Distribution

• Dedicated logistics team to provide solutions for IVD kit distribution
• Approved couriers and worldwide delivery capabilities
• Bespoke distribution strategy per product
• Partners with global distributors
• Cold chain specialists

Regulatory Compliance

• GMP compliant and ISO13485 accredited facility
• Independent quality and regulatory personnel
• Facilitation of customer / regulatory audits
• Regulatory compliant labelling