Client: Early-Stage Clinical Biotech Startup
Duration: 9 Months
Project Role: Project Lead - GMP Bridge Senior Partner
Location: USA
Project Overview:
GMP Bridge was approached by a biotech startup entering Phase I clinical trials, needing to quickly establish a scalable, GMP-compliant Quality Management System (QMS) to support their development pipeline. The challenge was to implement a robust system that adhered to industry standards without overstretching the company’s limited resources.
Our Senior Partner led the project, applying a phased implementation strategy that balanced compliance with operational efficiency and cost constraints.
Key Deliverables:
- QMS Design & Implementation: Designed a complete QMS from scratch, tailored to the startup’s needs, ensuring compliance with GMP standards while remaining flexible for future scaling.
- Process Standardization: Standardized critical processes, including document control, batch record reviews, and deviation management, to streamline operations and improve efficiency.
- Staff Training & Onboarding: Delivered targeted training programs for the startup’s staff, ensuring everyone was prepared to work within the new QMS framework.
Results:
- QMS Implementation on Time & Budget: The QMS was successfully implemented within six months, allowing the company to meet key milestones in its clinical trials while adhering to GMP standards.
- Improved Operational Efficiency: The standardized processes and training improved operational efficiency, allowing the startup to focus on product development without worrying about compliance risks.