The client engaged Vantage MedTech to develop a proprietary applicator and GMP-formulated cantharidin-based drug-device combination product under a Quality Management System (QMS)for precise and safe topical administration. The goal was to create an effective treatment for molluscum contagiosum that meets the critical unmet medical needs of pediatric and adult patients.
The Complexity
Vantage MedTech provided insight into gaps in Clients existing documentation.
Worked with client to fulfill documentation needs as identified by Vantage and the FDA.
Designed a single-use applicator for precise topical dosing, ensuring patient safety and treatment efficacy under a Quality Management System (QMS) supporting FDA submission.
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