Compliance House provides clients with consulting on FDA regulatory compliance and interpretation issues.  Compliance House is a small privately owned consulting firm that specializes in assisting companies with all aspects of FDA Regulations, including 21 CFR Part 11, Good Manufacturing Practices, Good Clinical Practices, Good Laboratory Practices, and Quality Systems Regulations for Medical Device Manufacturers.

What We Do

Compliance House offers consulting services for:

• FDA GxP Predicate Rules & 21 CFR Part 11

• Third-Party Independent Regulatory Auditing

• Risk Management (Identification, Analysis and Remediation)

• Disaster Recovery and Business Continuity Planning

• Policy, SOP and Template Development

• Information and Computer Security Assessment

• Infrastructure, Network & Instrument Qualification

• Computer System Validation

• Quality Management, Document Control and CAPA Systems

• Training Material Development and Presentations

• Project Management Support

Call Us Today!

Please contact us anytime! We look forward to hearing from you.