Pharma product launch readiness strategy
A successful product launch requires cross-functional coordination. SCx CMC Solutions empowers late-stage biotech teams to execute a complete pharmaceutical product launch plan, including 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 techtransfer, scale-up, and validation steps across the pharma product launch process. Also, we support tech transfer, PPQ protocols, and commercial readiness.
- 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
Packaging and Labeling
Packaging and labeling are pivotal in every pharma new product launch, ensuring both compliance and brand consistency. 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
Regulatory and Compliance
From eCTD preparation to pre-approval inspection readiness consulting, our delivers tailored support to help you meet evolving regulatory milestones.
- 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
Supply Chain Strategy
A well-executed SC strategy is central to a successful pharma product launch strategy, aligning supply logistics with regulatory approval timelines and demand planning.
- Demand and Supply Planning
- Vendor Selection / Contracts Negotiation
- Distribution and Logistics
- Shipping Lane Qualification
- Vendor management
- Digital Transformation
Strengthen Your Launch with Strategic Insights
Let’s Collaborate on Your Launch Readiness
From methods validation to the first customer shipment, SCx CMC Solutions supports every step of your product launch readiness, delivering leadership, and technical depth validation to distribution.