Regenerative Medicine Analysis and Certification
Regenerative Medicine product analysis, testing and certification services, supporting research and development, manufacturing, regulatory approval and certification.
Intertek supports Regenerative Medicine clients and their products, such as regenerative drugs (proteins or small molecules) or scaffold materials. Regenerative Medicine is rapidly growing. It is an interdisciplinary field applying principles of engineering and life sciences to develop biological substitutes, typically composed of biological and synthetic components, with the aim of improving tissue regeneration. Development of these complex products is not without challenges. Intertek's expertise help to accelerate the development process and support the critical stages of approval and certifcation.
Intertek Regenerative Medicine Services:
- Biomaterial scaffold analysis and characterization
- Regenerative drugs
- Small Molecule Pharmaceutical Analysis
- Growth factor / Protein Analysis
- QC Testing Services
- Stability Studies
- Extractables and Leachables
- Biomechanical testing of scaffolds
- Physical Characterization Techniques
- Management System Certification
- Notified Body Reviews for the Medical Device Directive
- FDA 510(k) Third Party Reviews
Intertek offers characterisation services for scaffold materials and products:
- Collagen Analysis
- Polymer Analysis
- Polymer / Ceramic composite analysis (such as trace metals analysis)
- Determination of scaffold processing residuals such as detergents or antibiotics
Request more information to see how Intertek can help your organization with Regenerative Medicine Analysis and Certification.