Creating and Managing Reliable, Cost Effective, Compliant Supply Chains for Clinical and Commercial Products
Whether your company's goal is the supply of clinical materials or post-approval commercial production, Trout Creek Consulting can help you create and optimize your supply chain. The CMC / Life Science Supply Chain services are geared towards the needs of early stage to mid-size life science companies.
Services
- Supply chain strategy definition
- Supply chain risk assessment
- Qualification, selection, and onboarding of CMO(s), suppliers, service providers, and 3PL
- For both new products and transfers of existing products
- RFP and technology transfer package preparation
- Negotiation of development, supply, and quality agreements
- Project management through technology transfer, process development, scale up, and production of clinical and validated commercial product
- Product development and process engineering
- Economic analysis to determine development costs, COGS, and capex
- Sales & Operations Planning (S&OP)
- cGMP audits
- Field Alert Report (FAR) response
- Due diligence and integration of acquired products