From Pre-IND to Impact
Accelerating biotech success through strategic guidance and executional excellence
Industries We Serve
Emerging Biotech
Contract Development and Manufacturing Organization
Cloud Biopharmaceutical
Strategic support for lean teams advancing from pre-IND through clinical development to commercial launch.
Cloud Biopharmaceutical
Contract Development and Manufacturing Organization
Cloud Biopharmaceutical
Empowering decentralized and outsourced teams with integrated regulatory and operational execution.
Contract Development and Manufacturing Organization
Contract Development and Manufacturing Organization
Contract Development and Manufacturing Organization
Collaborating with service providers to align development plans, streamline delivery, and enhance client outcomes.
Academic Institutions
Contract Development and Manufacturing Organization
Contract Development and Manufacturing Organization
Partnering with academic innovators to turn discoveries into commercially viable therapies through expert regulatory and operational guidance.
Our Solutions
Development and CMC Program Management
Development and CMC Program Management
- Pre-IND to GMP integrated timelines
- Cross-functional team coordination
- Timeline acceleration strategies
- Vendor selection and management
- Risk mitigation planning
- Budget monitoring alongside scope
Engineering and Technical Operations
Development and CMC Program Management
- Commissioning, Qualification & Validation (CQV) programs
- GMP facility design and operational readiness
- Process Validation and Tech transfer
- Computer System Validation (CSV)
Quality Engineering and Compliance
Vendor Identification and Management
- GMP Quality Risk Management
- Lean CQV execution strategy
- Quality / Regulatory strategy
- FDA / Health Authority interaction strategy
- Data Integrity Assessments
Vendor Identification and Management
Vendor Identification and Management
- Vendor qualification processes
- CRO/CDMO selection and management
- Contract negotiation support
- Scope monitoring
- Performance monitoring processes
Strategic & Financial Risk Management
Strategic & Financial Risk Management
- Risk assessment and mitigation
- Financial milestone tracking
- Budget planning and cost optimization
- Budget forecasting
End-to-End Strategic Guidance for Biopharma Success
Our Values
What Sets Us Apart
Why Industry Experts Trust Our Founders
