Exclusive Services

At QualiStrategix, we work as a true extension of your team, tailoring our support to match your development stage, regulatory needs, and operational goals. Our approach is rooted in clarity and purpose, beginning with a deep understanding of your science, systems, and people to craft strategies that drive progress, not just compliance.

We believe quality and regulatory excellence should fuel innovation, not slow it down. Every engagement is built to strengthen your team’s confidence and capabilities, ensuring lasting impact well beyond project completion

Regulatory Affairs Strategy & Execution

FDA & EMS Submissions support
International Product Registration
Regulatory Gap Assessments & Roadmaps
Lifecycle Regulatory Support

Quality & Compliance Systems

QMS Design, Implementation, and Remediation (ISO 13485, 21 CFR Part 820)
Audit Readiness & Response
CAPA, Change Control, Risk Management
eQMS Implementation & Optimization
Supplier Quality Oversight

Operational Excellence & Strategic Leadership

Lean Six Sigma Project Management
Process Optimization & Root Cause Analysis
Strategic Quality & Regulatory Road-mapping
Fractional QARA Leadership & Team Development
Cross-functional Project Management

Technical & Medical Writing

Standard Operating Procedures
Regulatory Document Drafting & Review
Technical Protocols & Reports
Submission Documentation
Cross-functional Communication Materials