01
Quality Management Systems
Design and implement QMS aligned with FDA 21 CFR Part 820 (QMSR) and ISO 13485 — sized for startups through enterprise.
Services
Regulatory and quality consulting without borders
Global experience and relationships on every continent, brought to every quality and compliance engagement.
02
FDA Inspection & Audit Readiness
Mock inspections, gap assessments, 483 and warning letter response, and supplier audits.
03
Validation & Computer System Validation
Process, equipment and software validation including 21 CFR Part 11 data integrity.
04
Product Investigations & CAPA
Root cause analysis, complaint handling and corrective actions that actually close.
05
Training & Document Control
Training matrices, SOP harmonization and document management that stays inspection-ready.
06
Regulatory Project Management
Hands-on leadership for submissions, site launches and quality system remediation.
Frequently asked questions
Do you work internationally?
Yes. Alpha Quality Solutions works across the globe and has relationships on every continent. We support companies and international operations worldwide with an approach tailored to each project.
Which regulations do you cover?
FDA 21 CFR Parts 210/211, 820 and 11, ISO 13485, ISO 14971 and ISO 9001, among others.
Can you help a small startup?
Absolutely. We scale quality systems to your stage so you build only what you need, when you need it.
Global expertise. Ready for your next audit?
A free 30-minute compliance consult — no pressure, straight talk.