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.
Cymorg and GrayMatter have teamed up to deliver AI-powered training designed for life science organizations. By combining Cymorg’s smart learning platform with GrayMatter’s industry expertise, we help clients build workforce capability, streamline compliance training, and enhance operational performance.
We work with Barker to deliver end-to-end project support for life science facilities—from planning and management to construction. Together, we ensure projects are completed safely, efficiently, compliantly, and ready for operation.
We team up with Amphenol/Kaye to help clients qualify temperature mapping and environmental monitoring systems across their facilities. By combining Kaye’s leading validation equipment with our expertise in validation and compliance, we deliver a turnkey solution for temperature control compliance.
We work with OneVector to deliver advanced technology solutions for the life sciences industry, combining their expertise in IT compliance, digital transformation, big data, machine learning, and cloud architecture with our industry knowledge.
GrayMatter Partners collaborates with Panthera BioSolutions to help emerging biotech companies rapidly achieve GMP readiness. Combining GrayMatter’s quality and CQV expertise with Panthera’s ready to use cleanrooms and R&D infrastructure, we enable efficient, compliant, and scalable operations.
We combine HealthStar’s expertise in building and customizing pharmaceutical machinery, including turnkey BFS lines, with our support in validation, compliance, and training. Together, we help life sciences organizations optimize manufacturing and packaging operations.
Together with Salent Solutions, we provide unified CQV strategy and execution—from early project planning through commercial readiness—along with end-to-end validation support, cGMP implementation, audit and PAI preparation, and compliant water system monitoring.
We work with Adhvan Healthcare & Life Sciences to drive growth and innovation in the life sciences sector. By combining their strategic consulting and investment support with our expertise in project execution, validation, and operations, we help organizations scale efficiently and bring innovations to market faster.
We work with Reliable Building Services (RBS) to support life science facilities with commissioning, systems integration, and operational readiness. Combining RBS’s 35+ years of expertise in facility management, HVAC, and controlled environments with our guidance, we ensure building systems run reliably and efficiently.