Pharmaceutical outsourcing lets a sponsor company focus on its core business by having manufacturing and regulatory functions assumed by MPI.  Freed from devoting energy to areas that are not in its expertise, the sponsor company may focus its resources on meeting its customer’s needs.  Pharmaceutical outsourcing becomes increasingly important as sponsor companies search for ways to bolster productivity and keep down fixed costs.

MPI is experienced and understands the technical and regulatory impediments along the drug development path.  MPI will leverage our understanding of the manufacturing process and regulatory environment as it develops the sponsor company’s products.  To that end MPI has a proven capability of developing a process that is robust, transferable, and scalable to meet clinical trial requirements through commercial manufacturing needs of our sponsor.  A small sampling of what MPI can offer includes:
 

* Assess risks

* Provide pilot batch through commercial manufacturing capability

* Make cGMP assessments and guidance

* Provide process development to reduce process variability

* Provide validation strategies

* Provide API raw material sourcing and quality acceptance

* Develop a manufacturing plan

* Develop cost estimates based on need

* Conduct Failure Mode Analysis (e.g. FMECA and FTA)

* Perform gap analysis

* Establish timeline estimates