Regulatory Affairs & Compliance
Regulatory strategy, FDA and EMA submissions, and 21 CFR Part 11 compliance — so your path to approval is clear and your organization stays audit-ready.
Life Sciences Consulting · Regulatory & Quality
Compliance and quality, engineered for life sciences.
ICR Horizon helps pharmaceutical, biotech, and medical device companies achieve and sustain regulatory compliance and GxP quality — with the validation and technology expertise to make it hold up under inspection.
Partnering with
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Labs
What we do
Two disciplines. One standard: inspection-ready.
We focus deeply on the two areas that determine whether a life sciences company can bring products to market and keep them there — regulatory compliance and GxP quality & validation.
Quality, GxP & Validation
Quality management systems, GMP/GCP/GLP compliance, and computer system validation (CSV/CSA) with rigorous data integrity — quality that stands up to scrutiny.
Core capabilities
Where life sciences meets technology
Regulatory Strategy & Submissions
IND, NDA, ANDA, and 510(k) support with clear regulatory pathways.
Data Integrity & Part 11
ALCOA+ data integrity and 21 CFR Part 11 electronic records compliance.
Computer System Validation
CSV and risk-based CSA for GxP systems, from planning to reporting.
Audit & Inspection Readiness
Mock audits, gap assessments, and remediation ahead of FDA inspections.
Why ICR Horizon
Consulting that speaks both compliance and technology.
Regulated industries live at the intersection of strict quality expectations and increasingly complex systems. We bring both — seasoned regulatory and quality practitioners who also understand validated systems, data, and automation.
- Technology-enabled. Deep computer system validation, Part 11, and data integrity expertise — not just paperwork.
- Senior-led. Experienced consultants on every engagement — the people doing the work are the ones you meet.
- Inspection-ready. Everything we deliver is built to withstand FDA, EMA, and notified-body scrutiny.
- Pragmatic. Risk-based, right-sized compliance that protects patients without slowing you down.
01
Assess
Gap analysis against applicable regulations and current quality posture.
02
Plan
A risk-based, prioritized roadmap tailored to your product and stage.
03
Execute
Hands-on delivery — documentation, validation, and remediation.
04
Sustain
Ongoing support to keep systems and quality inspection-ready.
Let's raise the bar
Ready to make compliance a strength, not a scramble?
Tell us where you are in your regulatory or quality journey. We'll show you the fastest, most defensible path forward.