Biotech CDMO moving from R&D into Phase 1 clinical manufacturing
A quality system built for Phase 1 — biotech CDMO
The challenge, in operational terms
Moving out of R&D into Phase 1 clinical manufacturing, with no internal QA, a scientific team unfamiliar with regulatory and quality process, and a limited budget.
What I did, including the assessment method
I mapped the business processes, ran a gap analysis, and designed a QMS sized for where they were and able to scale.
What was delivered
Then an implementation roadmap, and mentoring for the QA person they eventually hired.
Related services
Design & Implementation of Tailored Quality Systems
Building a quality system for a company moving into regulated manufacturing, or fixing one that's stopped working. Sized for where you actually are, and built to grow rather than be replaced.
For: companies with no system, or with one that's become unusable.
Who you'd be working with.
I'm Antiksha Joshi. I've spent 28 years in pharmaceutical and life sciences quality across three continents. I am Chair of Women in Pharma, ISPE Australasia Affiliate.
I also write and speak on quality systems for various knowledge sharing organisations and online publications.
My background is in microbiology, and I hold a diploma in counselling, which sounds like an odd combination until you've watched a technically sound quality system fail because nobody could be persuaded to use it.
Whoever you speak to on the call is the person who does the work.
