Drug Combination Products
Our scientists provide full-service medical device and combination product support through the entire product development cycle and in post-market situations. From medical devices for surgical, spinal, cardiovascular, urology, neuromodulation, and diabetes, to combination products including biologic delivery devices and implants our scientists are experts at developing protocols and analyzing these products and materials.
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Techniques available include:
- TGA, DSC, SEM, HPLC with UV-vis, RI, ELSD, and MS detection, GPC, GC with FID, TID, and MS detection. FTIR, DLS, NMR, and others
What Necessitates Device or Drug Device Combination Product Characterization?
- Routine product development testing such as assay & impurities, raw materials qualification and stability studies
- Regulatory considerations such as extractables & leachables assessment
- Performance tests such as degradation or drug elution rate
- Product failure investigations
Our Scientists have experience with:
- Coronary Stents
- Drug-Eluting Coronary Stents
- Drug-Coated Stents
- Antimicrobial Catheters
- Polyurethane Catheter
- Orthopedic Applications
- Bone Cement, Including Antibiotic
- Bone Graft Substitutes
- Orthopedic Prostheses
- Dental Materials
- Ophthalmic
- Contacts
- Glasses
- Wound Care
- Including Those for Biological Dressings
- Sutures
- Drug Delivery & Drug-Combination Products
- Implants
- Drug-Eluting Beads
- Ocular Applications
- Photodynamic Therapies
- Membranes & Filters
- Flexible Tubing, Containers, Packaging, & Protective Products
- Coatings
- Other Medical Devices
Let’s work together to achieve your vision
Ready to get started? Click Get a Quote, or talk to an expert first if you’d like help in defining your project scope.