Quality Compliance

Our client: A small biotech start up company required quality and regulatory guidance.

This client engaged Safis to assist them with regulatory guidance and to build their Quality Systems 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 SOPís, training, third party vendor oversight and performed audits. Additionally, Safis developed regulatory submission and a clinical trial strategy in addition to providing assistance with FDA filing and negotiations.