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.
What We Can Do For You
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
We are experts in facilities, equipment, process, and analytical method validation. We can prepare comprehensive Validation Master Plans and assist you in establishing documentation standards that are practical and compliant. Using our extensive library of protocols and procedures, we can prepare validation protocols, standard operating procedures, quality test methods, and production batch records.
We can help you improve process performance following product commercialization, speed investigations of manufacturing deviations, or troubleshoot technical challenges. We can also optimize ongoing manufacturing operations for both clinical and commercial campaigns by developing staffing models, cost of goods models, operational efficiency programs, and cost reduction strategy recommendations.