Our Services
We'll help you simplify the GMP gray area.
Business Strategy
- Interim Leadership, Fractional C-Suite and Program Development
- Fund Raising, In/Out Licensing, Tech Transfers, Mergers and Acquisitions Assessments, Due Diligence, Alliance Management
- Manufacturing Strategy Development, Build vs. Buy Analyses
- Executive and Leadership Coaching, Coaching for high performing teams
- Digital Transformation
- Quality Culture Establishment
Quality and Compliance
- Phase-Appropriate cGMP Implementation, GMP/Regulatory Roadmaps
- Project/Program Management, CDMO/CMO oversight
- Risk Based Supplier Management, Internal Audits, PAI Readiness and Mock Audits
- cGMP Facility Design, Construction Management, Start-up, Commissioning, Qualification, Validation, Facility/Operations Management, Tech transfer
- Process, Cleaning and Cold Chain Validation
- Regulatory strategy, submissions and communications
- GxP Training, Error Reduction
Innovation
- cGMP Capacity Enablement
- Hybrid Manufacturing models via existing cGMP facilities and capacity
- cGMP Capacity Establishment for new Life Science Ecosystems
- Onshoring options for manufacturing in the USA
- Suite of Software Tools Designed for Maximizing GxP Operational Efficiency
- Gen-AI based Interactive GxP Training Platform
- AI-based predictive analysis tools
- External Partner Network - CROs/CDMOs, Testing Laboratories, Equipment Providers, Service Providers & Technology Partners
Industry Partners
We partner with industry leaders to provide our clients with end-to-end turnkey solutions.
CROs/CDMO/CMOs | Analytical Testing Labs | Staffing Agencies | Equipment Providers | Real Estate Firms | Construction Companies | IT/Automation Companies | AI Developers | Electronic Systems Providers | Storage and Warehousing Facilities