Sebald Consulting

Sebald Consulting provides practical GMP compliance and Computer Systems Validation (CSV) support for biotech, pharmaceutical, and medical device organizations.

Our work focuses on helping companies understand regulatory expectations, close compliance gaps, and produce documentation that can withstand regulatory inspection. Many organizations have capable teams but need experienced guidance to ensure validation and compliance activities are defensible and efficient.

Sebald Consulting works directly with client teams to assess risk, clarify regulatory requirements, and implement practical solutions. The goal is not theoretical consulting, but clear deliverables and inspection-ready outcomes.

Typical areas of support include:

• Computer Systems Validation (CSV)
• 21 CFR Part 11 assessments and remediation
• General GMP risk assessments and gap analysis
• Validation planning and execution (IQ/OQ/PQ)
• Audit readiness and remediation of findings
• Documentation development and review
• Support for critical compliance projects

Projects range from targeted assessments to hands-on execution of validation and remediation activities. Sebald Consulting supports both early-stage biotech companies building compliance programs and established pharmaceutical manufacturers addressing new systems or regulatory expectations.  We can also support special engineering projects.

The focus is straightforward: listen to the customer, understand the issues, implement practical controls, and deliver clear, defensible GMP documentation and validation results.