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
- 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.
- 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!