Our client: A small biotech startup company required quality and regulatory guidance.
This client engaged Safis to assist them with regulatory guidance and to build their quality system after acquiring a drug candidate with two complete Phase 3 studies.
Scope included manufacturing, storage facilities, drug supply manufacturers, analytical labs, packaging, CROs, data management facilities, and distribution facilities. Safis developed and delivered SOPs, training, third-party vendor oversight and performed audits. Additionally, Safis developed regulatory submission, a clinical trial strategy and provided assistance with FDA filing and negotiations.