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TESTING SERVICES FOR

Combination / Convergent-Technology Products 

AppTec has over 15 years experience serving both medical device and biologics manufacturers. Our unique and proven background is a significant advantage as a provider of testing for preclinical, regulatory and lot release studies for combination/convergent-technology products. 

Understanding that communication between regulatory agencies, manufacturer and testing lab is critical to ensure success in combination product development, AppTec – with exceptional expertise and attention to detail – becomes part of your design team, working closely with you to help bring your product from research to proof-of-concept to commercial launch.  

Product Experience

·    Biomaterials

·    Implantable / Injectable / Transdermal Drug Delivery

·    Coatings / Surface Treatments

·    Fusion Biologics  

Specific Study Experience

·    Device/Drug infection models

·    Device-delivered drug response

·    Device-delivered nanoparticle

·    Collagen bioabsorption

·    Efficacy of a device-delivered drug (insulin, antibacterial)

·    Critical bone defect

·    Chronic inflammation reaction

·    Biodistribution of drug, collagen, toxin, particle (ELISA, PCR,

    radiolabeling)  

General Service Capabilities

·    Materials Evaluation & Model Development

·    Biocompatibility / Safety Studies

·    Toxicology Discovery / Safety Studies

·    Stability Storage & Analytic Testing

·    Sterilization Validation Studies

·    Packaging Integrity Studies

·    Pathologic Tissue Analysis

·    Identification & Quantitation of Agent Distribution