Medical Device Consulting services
- Product Development
- Design Controls
- Risk Analysis/Risk Management
- Quality System Regulation (QSR) Implementation and Compliance
- Current Good Manufacturing Practice (cGMP)
- Corrective and Preventive Action (CAPA)
- Design History File Remediation
- Regulatory - Change Evaluation, 510(k), PMA, Deficiency Letter
- Process, Method, Software Validation
- Manufacturing Process Development
- Failure Analysis
- Materials Science
- Human Factors Analysis, Usability Assessment
- Combination Product Development
Pharmaceutical Consulting services
- Quality by Design (QbD)
- Container/Closure System Development and Qualification
- Quality System Regulation (QSR) Implementation and Compliance
- ICH Q1A-F Stability Compliance
- Regulatory - Change Evaluation, NDA, ANDA
- Manufacturing Process Development
- Process, Method, Software Validation
- Risk Analysis/Risk Management
- Combination Product Development
Project managment and business strategy
- Project/Program Strategy Development
- Project Execution
- Lifecycle Planning
- Design and Technology Transfers
- Product Commercialization
- Interim Leadership Services