Trusted Quality Assurance Across the Product Lifecycle
Quality assurance is a broad process for preventing quality failures. Our QA team is involved in all stages of a product’s development to commercialization: raw materials procurement, production, testing, packaging, and release to customers. In research and development phase we are approached to ensure quality of development is not only consistent but well documented to support clinical phases and scale-up of production. Our specialists in monitoring, inspecting, validation and GxP auditing have extensive experience in all aspects of manufacturing and operations to support compliance.
All QA team has between 10 to 30 years of experience implementing QA from start-up phase to commercialization for all types of products. Our combined expertise in QA includes:
Global Quality Management System development from simple cosmetics to complex biologics
Qualification of vendors for supply of API, components, services, laboratories, etc.
QA inspections
Instrument qualification and validation
Process qualification & validation
Qualification of utilities (aseptic & sterile production)
Computer software or System validation
At AXSource we provide quality control (QC) services in supporting the validation, transfer, and release of your pharmaceuticals. QC Team will identify mistakes, errors, or missed requirements before release. AXSource partners with top testing laboratories that are certified by agencies to provide the quality of services relied upon by our clients. No need to identify and hire staff – our partners readily provide all the experts you will require for your products whether you are in the pre-clinical phase, clinical, or commercial of your business. Our combined expertise in QC includes:
- Product Specifications and Release Management.
- Testing Protocols.
- Method Transfer & Method Validation.
- Compendial Methods.
- Batch Release of OTCs, pharmaceuticals, and biologics before sale to market.
