Opportunities exist for collaboration with us through Product Distribution, Contract Product Development, and Contract Manufacturing.
Collagen Matrix has existing global alliances with industry leaders for distribution of our diverse, high-quality collagen medical devices that support the body’s natural ability to regenerate in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair. These distribution alliances are structured with either private branding or our Collagen Matrix brands.
We have a pipeline of products at various stages of development. The commercialization of these products will be achieved by partnerships and joint ventures with established healthcare entities.
Global distribution and strategic alliance opportunities are available for certain Dental, Spine, Orthopaedic, Dural Repair, Nerve Repair and Cardiovascular product portfolios.
If you are interested in developing a Product Distribution partnership, please contact us.
We have the expertise and the experience in development of collagen and mineral based medical devices to meet specific clinical needs.
Our experienced leadership team and R&D scientists have diversified backgrounds and are knowledgeable in product life cycle management from design to commercialization. Our proven track record ensures customized product development with speed to market.
We offer contract development or co-development of products with expertise in the following areas:
- Design Controls
- Process Development
- Quality Control Testing Requirements
- Pre-clinical and Clinical Testing Requirements
- Regulatory Approval Pathways
- Animal Tissue Handling and Processing Requirements
Applications in clinical end markets include:
- Burn care
- Cell delivery
- Drug or biologic delivery
- General surgery
- Growth factor delivery
- Minimally-invasive delivery
- Plastic & reconstructive
- Sports medicine
- Tissue engineering
- Wound care
If you are interested in a contract or co-development partnership, please contact us.
Our facilities host state-of-the-art class 10,000 (ISO Class 7) controlled environments for manufacturing and quality control laboratories for in-process and finished product testing. We are registered with the FDA as a medical device manufacturer, contract manufacturer, and specification developer. Our facilities and quality systems are in compliance with FDA GMP/QSR, certified to ISO 13485 and MDSAP, and in compliance with all global animal tissue standards.
With these controls in place and our experience in manufacturing collagen and mineral based devices, we can provide short and long term contract manufacturing services for a variety of medical and biotechnology markets. Our capabilities ensure process customization with speed to market.
Our capabilities include:
- Audit Management
- Complaint Handling
- Design Transfer
- Distribution of Products
- Environmental Storage Studies
- Equipment Qualification, Calibration, and Maintenance
- Final Box Labeling and Assembly
- Labeling Design
- Manufacturing Batch Release
- Packaging Design and Validation
- Process Development and Validation
- Process Transfer
- Purified Water System Management
- Quality Control Testing
- Shelf Life Studies
- Shipping Simulation Study Design
- Sterilization Validation
- Supply Chain Management
With our manufacturing expertise, we can make outsourcing a viable option for your company.
If you are interested in a contract manufacturing partnership, please contact us.
Supporting the body's natural ability to regenerate