Tactical Expertise & regulatory compliance consulting
SCx CMC Solutions connects you with scientific consultants and specialists in regulatory compliance consulting and CMC execution. We are ready to bring strategic leadership across the CMC landscape and value chain.
However, we know experienced drug developers often need tactical expertise to solve a specific issue or fill a temporary gap. With consultants whose capabilities range from daily field operations to niche specialization, we’ll match you with the right support to step in where it matters most and drive meaningful progress.
Scientific
- Compaction simulation
- Flow Chemistry
- Biologics/complex molecules/Peptides/ Oligonucleotides
Outsourcing and Procurement
- Master Service Agreement Negotiation
- Quality/Technical Agreements
- Supply Agreement Negotiation
Engineering
- Continuous Manufacturing
- Spray Drying/Particle Engineering
- Drug/Device development and integration
Tech Services
- Scale up and Validation
- Risk Assessment Gap Analysis and Process Troubleshooting
- Tech Transfer Protocols and Support
- Equipment I/OQ
Supply Chain
- Cold Chain
- Serialization
- Controlled Substances
Quality and Compliance
- QMS Initiation and Implementation
- Quality Audits
- Documentation Control and Data Mining
Let’s Tackle Your Scientific Challenges
Whether it’s a formulation challenge or quality assurance for pharmaceuticals, SCx CMC Solutions connects you with experts who move your program forward.