Launch Readiness
A successful product launch requires cross-functional coordination. SCx CMC Solutions empowers late-stage biotech teams to integrate CMC, Supply Chain, and QA elements into a global Launch Readiness Plan. Our expertise enables your team to anticipate key challenges, align priorities, and achieve commercialization excellence.
Scale-Up and Validation
SCX CMC Solutions experts ensure methodical tech transfer, scale up, and process validation to facilitate the transition to commercial manufacturing.
- CMC gap analysis
- Risk Assessment
- Supply Planning and Scale-Up Strategy
- Tech Transfer Protocols/Reports
- Process Validation Strategy, PPQ Protocols and Reports
Plan for Smooth Scale-Up with Proven Experts
Nick
Pharmaceutical Science Expert
Kirk
Scott
Ray
Packaging and Labeling
Following clinical packaging, commercial packaging, and labeling expands compliance requirements. Our package engineers, QA, and regulatory experts are here to guide the way.
- Package Design and Testing Support
- Label Requirements, Design and Sourcing
- Packaging Validation
- DSCSA Compliance
Precision Packaging Starts with the Right Partners
Haneen
Designation
Scott
Emma
Ray
Regulatory and Compliance
Late-stage CMC regulatory and compliance demands evolve through Clinical Phase IIb and Phase III of the development lifecycle. SCx provides resources and guidance to build expertise within your organization.
- Supplier Audits
- Phase appropriate analytical methods qualification requirements
- eCTD and Regulatory Submissions / CMC Documentation
- Quality Management Systems
- Pre-Approval Inspection (PAI) Readiness
Navigate Approval with Regulatory Expertise
Patrick
Kirk
Elaine
Spandana
Supply Chain Strategy
Supply chain (SC) strategy establishes the infrastructure necessary to support mass production, maintain compliance, and meet market demands. SCx can build a SC roadmap fully integrating CMC, Quality, Regulatory, and Commercial Operations in your global LRP–aligning SC strategy with regulatory approval timelines and commercial objectives.
- Demand and Supply Planning
- Vendor Selection / Contracts Negotiation
- Distribution and Logistics
- Shipping Lane Qualification
- Vendor management
- Digital Transformation
Strengthen Your Launch with Strategic Insights
Ray
Founder & Principal Consultant
Scott
Clinical Trial Supply Chain and CMC Operations Specialist
Haneen
Emma
Let’s Collaborate on Your Launch Readiness
From methods validation to the first customer shipment, SCx CMC Solutions provides the expertise and leadership to help your product launch succeed.