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Solutions
Our Power is Numbers​
Our numbers speak for themselves. We consistently deliver for our clients by providing fast, quality support while maintaining compliance.
COUNTLESS VALIDATED SYSTEMS
All services in one place
We support organizations from small start-up companies to Fortune 500 companies. Our clients needs are constantly changing, so we are continually adapting and evolving in our approach.
Program Management
Quality Assurance
Quality Control
Validation
Program Management
- Capital projects management
- Cost / Scope / Schedule development
- Facilities master planning
- Facilities design support (Owners rep services)
- Project risk assessment
Validation
- Startup / Commissioning and validation services for equipment/systems and full facilities
- Cleaning validation
- Computer systems and software validation
- Spreadsheet validation
- Process validation
- Environmental monitoring (validation plus continued service)
- SOP writing
Quality Assurance
- Quality Management System design/development (phase-appropriate)
- Training in all areas of compliance, validation, etc. (GMP, GLP, GCP/GCLP, etc.)
- Quality audits (internal and external)
- Quality engineering
- Validation master planning
- Risk management and risk assessments
- Authoring, reviewing, and approving all types of controlled documents
- Resolution of deviations, investigations, and CAPAs
Quality Control
- Analytical method development, qualification, and validation
- Environmental Monitoring programs
- Authoring, reviewing, and approving all types of controlled QC documents
- Raw materials inspection/testing program
- In-process, release, stability testing programs
- Contractor management (CDMO, CRO, CTL, etc.)
