We specialize in the areas of Compliance and Validation to help ensure your firm
obtains and maintains  GxP-compliance.

Regulatory Services | Quality & Compliance Services | Validation Services | Technical Services

Regulatory, Quality & Compliance Services

  • Strategic Planning for FDA Facility Approval 
  • Facility and Pre-approval Audits 
  • 483, Warning Letter and Consent Decree Remediation Projects 
  • On-site assistance during FDA inspections 
  • Quality System Development and Implementation 
  • CAPA Management 
  • Supplier Controls 
  • Customized Training Programs 
  • Batch Record Review 
  • Audit Prep, Vendor and 3rd Party audits
  • Regulatory Submissions 

Validation Services

  • Equipment Validation 
  • Computer System Validation 
  • Cleaning Validation 
  • Process Validation 
  • Test Method Validation 
  • Utilities Validation 
  • Laboratory Instrument Validation 
  • Data Integrity Assessments
  • Gap Analysis 
  • Technical and Procedural Remediation
  • Functional Requirements, User Requirements, and Design Specifications 
  • Commissioning Documents, Site Acceptance Tests, Test Plans and Protocols, Protocol Execution and Validation Testing.
  • Site Validation Master Plans, Validation Master Plans, and Summary Reports.

Technical Services

  • Verification of Piping and Instrumentation Diagrams, Isometric Drawings, and Loop Sheets  
  • Document Research, Data Analysis, and Feasibility Studies 
  • Creation, Modification and Revision of Technical Manuals, Training Manuals, Administrative Guides, White Papers & Standard Operating Procedures  

Contact Us for Our Full List of Services!