Clinical
Quality
Assurance

LEADER COMPLIANCE
a Touchstone Technologies Inc. Company

Regulatory Auditing, Consulting, Risk Assessment, Vendor Support, and Training for Pharma, Biotech, Medical Devices, Cell & Gene Therapies,

and CBD Industries

"One should not aim at being possible
to understand,
but at being impossible to misunderstand."

Quintilian 35 AD

Our Mission

Our mission is to provide consistency and predictability of compliance for our clients so they can be sure that our work is of the highest quality and compliant with regulations. We pride ourselves on:

Compliance Excellence and
Client Experience Excellence

We deploy seasoned industry professionals and provide them the support they need to ensure compliance for our clients.

Services

Leader Compliance offers a comprehensive suite of services to ensure regulatory compliance for companies in the pharmaceutical, biotech, cell & gene therapies,
and medical devices industries.

Our Expertise

Quality Management System
Governance
Compliance Strategy
Risk Assessment and Mitigation
Audits
Training
Project Management
Clinical Data Management
Inspection Remediation
Inspection Prep
Inspection Hosting
Software Vendor Services

Clinical Trials

Our Disciplines

CQA

GLP
GCP
GCLP
GMP
GPvP
21 CFR 11 / Annex 11
Computer Systems Validation (CSV)
Data Integrity Audits & Remediation
AI
Clinical Data Management
Microbiology
Method Validation
CLIA
CAP