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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.
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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
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