Trusted by Healthcare & Life Science Organizations

Your Compliance.
Our Expertise.

Expert compliance consulting for healthcare, life sciences, and technology organizations. We navigate HIPAA, GDPR, ISO 27001, SOC 2, and FDA regulations — so you can focus on your mission.

100+
Clients Served
12+
Frameworks Covered
15+
Years Experience
0
Failed Audits

What We Do

How We Help

End-to-end compliance support across every stage of your program — from first assessment to ongoing advisory.

01

Compliance Readiness Assessment

Comprehensive gap analysis of your current compliance posture vs. required state. We deliver an actionable, risk-prioritized roadmap your team can execute immediately.

Gap Analysis Risk Scoring Remediation Roadmap Executive Report
Best for: Organizations starting their compliance journey
02

Privacy Program Implementation

Build and operationalize a robust privacy program covering HIPAA, GDPR, CCPA/CPRA, and state-level regulations. Includes policies, procedures, staff training, and DPO support.

HIPAA GDPR CCPA / CPRA Policy Development Staff Training
Best for: Healthcare, SaaS, and global enterprises
03

Security Framework Implementation

Design and implement NIST CSF, ISO 27001, and Zero Trust architectures. We guide you to certification and help you demonstrate security maturity to customers and regulators.

NIST CSF ISO 27001 SOC 2 Zero Trust
Best for: Tech companies and large enterprises
04

Regulatory Audit Preparation

Pre-audit mock assessments, evidence collection, control testing, and live support during FDA, OCR, or third-party audits. We prepare you to pass — every time.

Mock Audits Evidence Collection FDA 21 CFR Part 11 CAPA Management
Best for: Pharma, MedTech, and CROs
05

Ongoing Compliance Advisory

Fractional vCISO and compliance officer services. Stay ahead of regulatory changes, respond to incidents, and maintain continuous compliance as your organization scales.

vCISO Services Regulatory Monitoring Incident Response QMS Management
Best for: Organizations needing ongoing expert support

Sectors

Industries We Serve

Deep sector expertise means we speak your language and know your regulators.

Healthcare

Hospitals & Health Systems

Life Sciences

Pharma & Biotech

Medical Devices

MedTech & IVD

Health IT / SaaS

EHR & Digital Health

Financial Services

Insurance & FinTech

Clinical Research

CROs & Sponsors

Manufacturing

GxP & ISO 9001

Government / Federal

FISMA & FedRAMP

Our Toolkit

Frameworks We Work With

Deep expertise across every major compliance framework your business needs.

HIPAA
Privacy & Security Rules
GDPR
EU Data Protection
CCPA / CPRA
California Privacy Law
ISO 27001
Information Security Mgmt
NIST CSF
Cybersecurity Framework
SOC 2
Type I & Type II
FDA 21 CFR Part 11
Electronic Records
GxP / CSV
Good Practices & Validation
Zero Trust
Security Architecture
QMS / CAPA
Quality Management Systems
ISO 9001
Quality Standards
FISMA / FedRAMP
Federal Security

Our Story

PhD Scientist Turned Compliance Expert

ComplyEdge is led by Dr. Luv Kashyap — a former research scientist and Director of IT Security & Regulatory Compliance with 15+ years bridging science, technology, and regulatory requirements at Novartis, Alcon, and McKesson.

That cross-industry depth — from bench science to Fortune 500 IT security — is what makes ComplyEdge different. We understand your science, your systems, and your regulators.

PhD Scientist
HIPAA Expert
ISO 27001 Practitioner
GxP / CSV Specialist
GDPR / CCPA
Zero Trust Architecture
LK
Dr. Luv Kashyap
Founder & Principal Consultant
linkedin.com/in/drluvkashyap · Dallas, TX
"A lifelong learner and teacher. My journey from PhD scientist to IT security and compliance leader gives me a unique lens — I see the science, the systems, and the regulatory landscape together."
McKesson Director, IT Security & Compliance · 2020–Present
Alcon Assoc. Director, BISE Compliance · 2019–2020
Novartis Assoc. Director, Quality Systems · 2014–2019
Schedule a Call with Dr. Kashyap →

Ready to Get Compliant?

Book a free 30-minute consultation. No commitment. No sales pitch. Just expert guidance from someone who's been in your shoes.

Book Your Free Call Today

Get In Touch

Let's Talk Compliance

Tell us about your organization and compliance challenges. We'll respond within one business day.

Location
Dallas / Fort Worth, Texas · Serving Clients Nationwide