All rates are based on specialty area and scope of work services requested starting at $85.00* p/hr USD, expenses excluded. Please inquire for specific rates. Example service scopes are listed below
Engineering
- Design Review and Development
- Test and Verification Support
Compliance
- Regulatory Response Reviews
- Inspection Readiness
- Gap Assessment and Remediation Strategy Development
- Lean Initiatives
Validation
- Facility Systems
- Process Systems
- Computerized Systems (GxP)
- Equipment Systems (Manufacturing and Laboratory)
- Enterprise Systems (global)
- Product Performance Qualification
Quality
- Quality Manual Development [GCP/GVP/GMP]
- Supplier Quality
-
Quality Assurance
Document Management
CAPA
Deviation Management
Investigations -
+ Quality Management
QMS
NDA/ANDA
Computerized Systems -
Quality Auditor
Internal Controls
Third Party Vendor Audits