Pharmefex is devoted to helping you make sound operational decisions to support all your manufacturing, outsourcing, and facility requirements. We can help you manage outsourcing projects, conceive and implement strategies to build optimal development and manufacturing organizations, effectively communicate your CMC strategy, and efficiently manage your workflow to accelerate product development. We can also help you determine the optimal use or market for your existing manufacturing facilities.  If you are struggling with the difficult choice between capital investments in manufacturing facilities and infrastructure or outsourcing to support your short and long term manufacturing needs, we can provide guidance and recommendations that take into consideration the composition and timing of your product portfolio, the costs of building versus outsourcing, and the risks associated with development into the analysis.

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We can provide support for capital investments in new facility construction or for your outsourced manufacturing programs by:

• Providing input into equipment and materials selection and procurement
• Identifying outsource partners including CMOs and CROs that are the best fit for your requirements and manage CMO or CRO selection process
• Performing rigorous cGMP compliance audits of your facility or your selected CMO to insure appropriate sustainable regulatory compliance for your products
• Assisting in the design and construction of your manufacturing facility from preliminary technical and economic evaluations through start-up and validation
• Reviewing master and executed batch and testing records, and serve as person-in-plant during manufacturing campaigns at your CMO