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FAQ
A CMC lead can help map out your drug development strategy and identify challenges that may lie ahead. SCx consultants can prepare develop strategies, timelines and budgets critical for fundraising and give investors confidence in your business plan.
Vendor selection and partnering are fundamental for the success of early development projects, launch readiness planning and supply chain resilience. SCx advisors work across the CDMO marketplace to identify high-performance partners that meet the specific needs for your project.
Quality Management Systems for virtual companies are a requirement for compliance with cGMP regulations. SCx specialists can analyze your value chain and build phase appropriate QMS and SOPs for your stage of development.
Referrals, word of mouth, reputation and being an insider to the CMC community is the secret to finding the right technical expert. SCx consultants and its founders have worked with dozens of startup, late-phase biotech companies and CDMOs. Our network of professionals is made up of mid-to late-career experts that have chosen to enter consulting. SCx provides a cooperative environment to ensure your project has the right expert at the right time.
Drug development budgets can vary widely based on the molecule, dosage form, stage of development, and regulatory pathway. That said, early-stage CMC work alone can range from hundreds of thousands to a few million dollars.
SCx begins getting to know your organization with a Target Product Profile (TPP) and development strategy to help clarify requirements. From there, we gather high-level quotes from qualified CDMOs to create realistic budgets and identify potential risks early.