Quality Assurance

4P Therapeutics is committed to developing products that can safely and effectively deliver medicines to meet the needs of patients and physicians. The 4P quality system governs the design, development, testing, manufacturing, and clinical testing of device, drug, biologic, and combination products intended for human use. We achieve this by implementing design, development, and manufacturing processes in compliance with 21 CFR §210&211 (drugs), 21 CFR §820 (devices), and 21 CFR §3&4 (combination products). 4P typically utilizes a system-wide design control process to develop drug delivery products in compliance with 21 CFR §820.30.

4P can either take the lead to perform all quality functions for a product development program or can perform in a support role for our partners. Supporting functions include assessment and auditing, drug or device supplier qualification, and quality oversight.