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Outsourcing And Supply Chain Management

Pharmefex offers comprehensive CMC outsourcing and supply chain management services to help you develop outsourcing strategies that meet your needs and requirements throughout all stages of your product’s lifecycle. During product development, we can manage all activities including cell line development, cell bank preparation and testing, process development, analytical method development, and formulation development. We can support all nodes of the supply chain from the procurement of raw materials to managing outsourced drug substance and drug product manufacturing and overseeing the packaging, labeling, and distribution of finished goods. We can assist you in identifying and selecting contract service providers by developing detailed requests for information or proposal, performing technical site visits and compliance audits, and reviewing proposals and other contractor-supplied material to support the selection of the most suitable contractor for your project. We can support the negotiation of service contracts, technology transfer for project initiation at a new contractor and ongoing management of outsourced activities.

What We Can Do For You:

Our comprehensive approach can help you effectively plan and manage all stages of product development and commercialization by:
  • Identifying, selecting, qualifying, and managing service providers for all your development, manufacturing, and quality needs

  • Negotiating development, supply, and quality agreements

  • Developing and implementing strategies for logistics and cold chain management throughout your supply chain

  • Preparing or assessing systems for inventory planning and management

  • Modeling and planning supply chains to help ensure consistent and on-time delivery of clinical trial material, integrate material planning with sales and operations planning, and maintenance of proper inventory levels

  • Developing effective manufacturing facility strategies incorporating future utilization rates and plans for maximizing value of underutilized assets

  • Assessing product supply chain risk and assisting with implementation of risk mitigation strategies, such as establishing secondary sources of suppliers