Drug Delivery / Combination Products
Pharmaceutical companies who are entering the medical device industry turn to us for expert guidance and support with a range of drug delivery, combination, and companion diagnostic products. Some highlights of the projects we have worked on for pharmaceutical companies include:
- Vaccine delivery systems – Regulatory strategy, quality and design control audits, participation in project design teams, labeling review, review of design verification protocols, simulated use study, FDA submission preparation for device components
- Specialty biopsy needle for vertebral core samples – CE mark / technical file review, general quality assurance and regulatory guidance
- Topical treatment for Palmar-Plantar Erythrodysesthesia (PPE) – Regulatory background review and 510(k) preparation
- IVDs / Companion Diagnostics
