CMC Tech, LLC Information

CMC Tech, LLC is a BioPharmaceutical consulting company specializing in CMC development and manufacturing, spanning phase 1 through commercial products: Startups: • Process development and manufacturing strategy - Phase 1 clinical through commercial manufacturing - Strategy planning and execution leadership for development and manufacturing - Internal and/or external CDMO engagement and management - Identification of CDMOs • Regulatory strategy for CMC sections - Strategy creation and management - Technical writing contractor identification • CMC execution leadership for companies that do not require a full-time CMC leader • Audit of CDMO manufacturing and quality systems • Extensive Consultant network to assist you in finding the experts you need Small pharma: • Services listed above for start-ups that are tailored to your unique company needs, plus • CMC execution leadership - Fill temporary gaps during a talent search - Companies that only require a full-time CMC or project leader Multinationals: • Due diligence and audit services - Product acquisition or divestment - Independent voice during negotiations • CMC strategy and execution • Contractor engagement and management • Extensive Consultant network to assist you in finding the experts you need Venture Capital and Private Equity Investor Services: • Audit services of company R&D, manufacturing, CMC regulatory and quality systems - Documentation and/or on-site audits - Assessment of the company’s internal capabilities and potential gaps - Assessment of the company’s external partners and potential gaps - Product/process risk mapping • CMC strategy services - Strategy planning and execution - Strategy & resource gap assessment - Risk reduction mapping and remediation recommendations & resources - CMC execution leadership