Drug Delivery/Combination products present unique challenges in all aspects of product development from regulatory strategy to design and material considerations through devising and implementing testing methodologies.
Uniquely positioned to provide combination product development solutions
Ximedica’s integrated development process and diverse internal staff of generalists and specialists account for the demands of developing, testing, and validating Combination Products.
We Ensure Products Meet User Needs, Exceed Safety & Performance Standards
By working closely and collaboratively with pharmaceutical, biotechnology, medical device, and other core technology developers we develop combination products that:
- Assess risk for the system as a whole: inclusive of the compound, the device, the user, the environment, and the product’s manufacture
- Determine how patient convenience and compliance are evolving drug delivery and design towards these emerging needs
- Ensure the most efficient and effective path to regulatory approval within countries targeted for product launch
- Work closely with clients to ensure the appropriate balance between product performance and cost.
Our engagements span the gamut from implantable and invasive devices, through minimally-invasive interventional and diagnostic tools, and on to topical and other non-invasive medical products, including many that are self-administered or used by lay individuals.
Ximedica’s Medication Delivery Device Expertise includes:
- Topical (through the skin)
- Transmucosal (nasal, buccal/sublingual, vaginal, ocular and rectal)
- Injection (subcutaneous, intramuscular, intravascular, intrathecal, epidural)