Hourglass Solutions Inc. is a boutique management consultancy based in Clearview, Ontario, dedicated to navigating the intersection of Life Sciences, IT Integrity, and Regulatory Compliance.

We believe that compliance should be a driver of operational strength, not an administrative burden. Our mission is to move organizations beyond fragmented legacy processes toward structured, audit-ready, and scalable compliance frameworks.
What sets us apart is our Implementation-First Mindset. We don’t just define compliant processes, we ensure they are adopted, sustainable, and resilient. Whether you are navigating the complexities of the drug development lifecycle or safeguarding data integrity through digital transformation, Hourglass Solutions provides the strategic oversight and documentation rigor necessary to succeed in high-stakes regulated environments.

Services:

•	Regulatory Operations & eCTD Submission Strategy (FDA, Health Canada, EMA Submissions)
•	Quality Management Systems (QMS) Design & Implementation
•	Inspection Readiness (BIMO/PAI) & GxP Auditing
•	Data Integrity (ALCOA+) & 21 CFR Part 11 Compliance
•	IT Audit & IT General Controls (ITGC)
•	SOP Development & Process Standardization
•	Regulatory Project, Program & Portfolio Management
•	Fractional QA/RA Leadership Support
•	Digital Transformation & Audit Remediation

Hourglass Solutions Inc.

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