Quality
FDA cGMP Compliance Consulting
FDA cGMP expectations under 21 CFR Parts 210 and 211 require controlled manufacturing systems that protect product quality and patient safety. Viltis consultants help pharmaceutical and biotech organi…
The client situation
- Building or upgrading GMP quality systems
- Preparing for pre-approval or surveillance inspections
- Addressing deviations, OOS, or data integrity concerns
- Supporting tech transfer or new facility startup
How Viltis helps
Structured support, end to end
01
Step 1
cGMP gap assessments
02
Step 2
Quality system design and SOP remediation
03
Step 3
Batch record and documentation controls
04
Step 4
Training and governance models
05
Step 5
Inspection preparation and response support
FDA cGMP expectations under 21 CFR Parts 210 and 211 require controlled manufacturing systems that protect product quality and patient safety. Viltis consultants help pharmaceutical and biotech organizations design, assess, and remediate cGMP systems that stand up to inspection and day-to-day operations.
Typical deliverables
What engagement can produce
cGMP gap report
Prioritized remediation plan
SOP and form upgrades
Inspection prep packages
FAQ
Common questions
Do you only support FDA markets?
Our focus is FDA cGMP while coordinating with EU GMP expectations when clients operate multi-region programs.
Related proof
Biologics CMC PIP
CMC and quality oversight for a Phase III monoclonal antibody program at a CMO.
Need support with FDA cGMP Compliance Consulting?
Discuss this requirement with our team - scope, timeline, and delivery model.