Our Services

Precision-Tuned Services to Simplify Your Challenges

Qualistrategix helps life sciences companies build strong, audit-ready quality systems and navigate global regulatory requirements with confidence. We offer expert support in QMS design, FDA and EMA submissions, and international product registration. We also excel in technical and medical writing, turning complex science into clear, compliant documentation. With a focus on Lean Six Sigma and strategic leadership, we drive efficiency, compliance, and cross-functional success.

Quality & Compliance Systems

Build and maintain audit-ready quality 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

Regulatory Affairs

Strategy & Execution

Navigate global regulatory complexity with confidence.

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

Technical & Medical Writing

Translate science and compliance into clear, usable documentation.

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

Operational Excellence & Strategic Leadership

Drive performance, efficiency, and regulatory alignment.

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