Compliance & Standards
Pharmaceutical & Biotechnology
cGMP, inspection readiness, remediation, and validation support for drug and biologic manufacturers.
Regulatory landscape
Standards and frameworks in this category
Each topic links to an existing Viltis service page describing implementation, assessment, and remediation support.
FDA cGMP Compliance
21 CFR Parts 210/211 quality systems and manufacturing compliance.
Form 483 & Warning Letter Remediation
Observation triage, CAPA planning, and reinspection readiness.
CAPA, Deviation & OOS Remediation
Investigation quality, root cause, and effectiveness checks.
Process Validation
PPQ strategy, stage 1-3 validation, and continued process verification.
Cleaning Validation
Residue limits, protocols, and multi-product facility validation.
FDA Inspection Readiness
Mock inspections, documentation packs, and SME coaching.
Related engagement
Biologics CMC Analytical Dev. Consultant
Phase III biologics analytical development support with LCMS expertise and new CRO relationships.
Discuss pharmaceutical & biotechnology compliance
Share your current controls, upcoming audits, or remediation priorities.