Compliance built to move as fast as your science.
Hatlestad Consulting helps emerging biotech, pharma, and medical device companies build audit-ready quality systems —without the overhead of a full-time QA department.
Led by
Scott Hatlestad
Scott Hatlestad, Founder & President, works directly with quality teams at growing life science companies to build systems that hold up — from research and development through commercialization and everywhere in between.
20+
Years of GxP experience
FDA
Inspection-tested work product
CSV · CSA
21 CFR Part 11 · Annex 11 · ICH E6(R3)
What we do
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CSV/CSA
Computer system and software validation, done right the first time.
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Audit Readiness
Supplier audits and inspection prep that hold up.
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Quality Systems
Quality frameworks built to scale with you.
Scott provides a great depth of knowledge across a wide array of GxP and Computer Validation subjects. I appreciate his pragmatic, risk-based approach, and his dedication to working WITH the team and accomplishing the task at hand.
Jason M.
Senior Director
Regulatory Systems, Info & CS Validation
Commercial-stage dermatology biopharmaceutical company