Integrity | Expertise | Partnership
Building trust through deep domain knowledge and client-focused collaboration
Spyre: Your Compliance Champions
Our Journey
- 300+ systems validated (SAP, Veeva, Oracle)
- 250+ audits completed with 100% success
- 1,000+ professionals trained in GAMP5, ALCOA+, and GxP
- Certified in GAMP5, ALCOA+, ISO 13485
Our Vision
To be the global leader in life sciences compliance, transforming the regulatory landscape with smart, agile, and human-focused solutions that make a difference.
Our Mission
We exist to empower organizations with precision-driven, audit-proof systems that reduce risk, eliminate inefficiency, and enable fast, compliant growth.
Our core competencies
21 CFR Part 11
Annex 11
GxP compliance
CAPA systems
Regulatory training
Core Values
Integrity
We don’t cut corners — ever
Excellence
Flawless outcomes, from first step to final audit
Partnership
Your goals define our roadmap
Innovation
We embrace AI, DevOps, and smarter compliance tools
Impact
Every project contributes to safer, faster healthcare delivery
Global Impact
Our knowledge spans continents. But our focus is always local, personalized, and precise
Pharma
Supported global FDA audit success.
Biotech
Enabled regulatory approvals that unlocked funding
Healthcare
Ensured HIPAA, GDPR alignment across systems.
Information Technology
Delivered 21 CFR Part 11 and Annex 11 validation for cloud-based platforms, SaaS products, and enterprise tools
Core Values
These aren’t buzzwords — they’re our backbone:
This values-first approach is why our clients return. Again. And again.
Integrity
We don’t cut corners — ever
Excellence
Flawless outcomes, from first step to final audit
Partnership
Your goals define our roadmap
Innovation
We embrace AI, DevOps, and smarter compliance tools
Impact
Every project contributes to safer, faster healthcare delivery
Global Impact
We deliver excellence beyond borders:
Our knowledge spans continents. But our focus is always local, personalized, and precise
Pharma
Supported global FDA audit success.
Biotech
Enabled regulatory approvals that unlocked funding
Healthcare
Ensured HIPAA, GDPR alignment across systems.
Information Technology
Delivered 21 CFR Part 11 and Annex 11 validation for cloud-based platforms, SaaS products, and enterprise tools
Why Clients Love Us
- Tailored Compliance Plans: Built around your needs and tech stack.
- 24-Hour Response Time: Quick answers, quicker fixes.
- Engaging Training: On-site and virtual workshops that stick.
- Audit-Ready Results: Zero-finding audit success, time and again.
Clients call us their secret weapon. From spreadsheet validation to vendor audits, we dive deep.