Your Science Is Ready. Let's Make Sure Your Quality System Is Too.
We help IND-stage biotech and pharmaceutical companies respond to FDA findings and build quality systems that hold up under inspection.
Senior expertise. Direct access. No firm overhead.
We started Redwyn Advisory Group because we kept seeing the same thing: brilliant scientists building promising therapies, tripped up by quality systems that were never built to scale.
You get a PhD-level GMP expert who has been in the room during FDA audits, supported BLA submissions, and built quality programs from scratch — without the overhead of a large consulting firm.
We work independently, which means faster turnaround and more competitive pricing — without sacrificing depth or quality.
Fast
483 response drafts in days, not weeks
Direct
Senior expert from day one through delivery
Deep
PhD-level depth behind every deliverable
Affordable
Senior expertise without large-firm overhead
How We Can Help Your Team
Investigation & Rescue
483 response, OOS investigations, deviation management. When you have a finding and a deadline, we help you respond credibly and strategically.
Learn more →QMS Build-Out
Complete quality management system for IND-stage companies — SOPs, document control, training programs, gap assessment, and folder architecture.
Learn more →SOP Development
FDA-aligned SOPs with inline guidance notes. Stage-appropriate libraries from Pre-Clinical through Phase 3, written by someone who has used them in a GMP lab.
Learn more →Audit Readiness
Gap assessment, mock audits, reinspection preparation. Know where you stand before FDA walks through the door. We have been in that room.
Learn more →GMP Training Programs
Custom GMP training for your team — cGMP fundamentals through OOS investigation best practices. Full curriculum, assessments, and training records.
Learn more →Data Integrity Programs
ALCOA+ compliance, 21 CFR Part 11 assessments, audit trail requirements, and data integrity remediation built to FDA 2018 guidance standards.
Learn more →Built for the Companies That Need It Most
IND-Stage Biotech Companies
Pre-clinical through Phase II companies building their first quality infrastructure. Practical systems that grow with you — not enterprise-level complexity you do not need yet.
CDMOs & Contract Laboratories
Organizations managing quality across multiple clients and complex testing workflows. Investigation expertise and systems that work at scale.
Companies With Active FDA Findings
You have a 483, an open OOS, or a Warning Letter. The clock is running. We help you respond well — fast. Flat fee. No surprises.
Teams Without In-House QA
Early-stage companies where everyone wears multiple hats. We serve as your fractional QA partner — senior expertise without a full-time hire.
How Every Engagement Starts
Free Discovery Call — 30 minutes
Tell us what is going on. We ask questions. No commitment. Book at calendly.com/redwyngroup-info/30min.
Fixed-Price Proposal — within 24 hours
Clear scope, timeline, and price. No hourly uncertainty. No surprises.
Sign SOW & NDA — we start immediately
50% deposit to initiate. The FDA clock does not wait and neither do we.
Delivery + 30-day support included
Final documents delivered. Available for 30 days post-delivery at no additional charge.
Book your free 30-minute discovery call
No commitment required. Tell us where you are and we will tell you honestly what you need — even if it is less than you expected.
Book at Calendly → Or email: info@redwyngroup.comYour pipeline deserves the right quality partner.
Every engagement starts with a free 30-minute discovery call. No commitment, no pitch deck — just a conversation about where you are and how we can help.
Book Your Free Discovery Call