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 companys internal capabilities and potential gaps - Assessment of the companys 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