Quality System Buildout for Gene Therapy IND Submission
CLIENT OVERVIEW
An early stage gene therapy company developing multiple AAV programs with limited internal quality infrastructure.
CLIENT CHALLENGE
The company required a Phase-Appropriate quality system to support its IND submission. Deviations, CAPA, and change control workflows lacked structure, raw material oversight was limited, and quality agreements with CDMOS were not yet established.
PIONEER ENGAGEMENT
Designed a Phase-Appropriate quality system aligned with ATMP expectations
Implemented deviation, CAPA, and change control workflows
Established raw material release and vendor qualification program
Developed quality agreements for plasmid, vector, and DP manufacturers
Provided CMC structure and content for IND Module Three
Delivered internal quality system training
KEY DELIVERABLES
Quality Manual and SOP set
Deviation, CAPA, change control workflows
Raw material qualification program
Quality agreements
IND CMC content
OUTCOME
The IND package was submitted on schedule with no major findings, and the company entered clinical development with a scalable quality foundation.
