GMP Quality Consulting Services
Four packages. Every engagement scoped specifically for your situation. Fixed-price proposals within 24 hours of your discovery call.
Package 03 — GMP Investigation & Rescue
Flat fee per investigation. When you have a finding and a deadline, this is where we focus. 483 response, OOS investigations, deviation management — the work that cannot wait.
483 Observation Response
Per-observation response drafting, cover letter, CAPA table, exhibit review, complete package ready to submit within the 15-business-day window.
OOS Investigation Support
Phase I review and gap remediation through full Phase I + Phase II investigation. Written investigation report, product disposition support, CAPA development.
Deviation Investigation
Triage, root cause analysis using 5-Why or Fishbone methodology, deviation report writing, CAPA plan development. We help get past surface-level causes.
Audit Defense & Reinspection Prep
Commitment tracker build, evidence binder review, mock audit of cited areas, team preparation, inspection day phone support, post-inspection debrief.
Complete Service Menu
Package 01
QMS Build-Out
Foundation Package
Complete GMP quality system from scratch — gap assessment, folder architecture, Master Document List, core SOP framework, investigation SOPs and forms, CAPA, change control, data integrity, vendor management, equipment management, training system, controlled copy system, setup session, quick reference tools, and 30-day check-in. 19 deliverables.
Two tiers: template delivery or fully built by Redwyn
Package 02
SOP Development
Quick Start Documentation
Stage-appropriate SOP library with inline guidance notes, branded template, MDL, cross-reference map, approval signature pages, revision history tables. Pre-Clinical (8 SOPs) through Phase 3 (25 SOPs) or fully custom. Add-ons: training workshop, controlled copy setup, BTR templates.
Forms and validation add-on available
Package 03
Investigation & Rescue
Urgent • Crisis Support
Situation assessment, document review, root cause analysis, CAPA development, investigation report rewrite, gap remediation plan, post-crisis SOP updates, and closure documentation. Same-day or next-business-day triage call. 8 deliverables included.
Flat fee per investigation
Package 04
GMP Training Programs
Team Development
Training needs assessment, custom curriculum, slide deck, participant workbook, knowledge assessment, training records, facilitator guide, and certificates of completion. Topics: cGMP fundamentals, OOS investigations, data integrity & 21 CFR Part 11, deviation & CAPA, SOP authoring, OOT trending, method validation fundamentals.
Per session or full program • Virtual or on-site
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.
Not sure which package fits?
That is what the discovery call is for. Tell us what is happening and we will tell you honestly what you need — even if it is less than you expected.
Book a Free 30-Minute Call