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