Regardless of your need in product areas including therapeutic proteins, monoclonal antibodies, biosimilars, or cell therapies, our broad range of services can help enhance your company's value every step of the way from early stage development to approval, launch and commercialization.
Our extensive product, process and analytical development experience enables us to help you transition your products from discovery to the clinic and to market faster and with less expense and risk. Whether your product is in pre-clinical development, clinical trials, or already on the market, we can help increase its value by identifying opportunities for yield improvement, enhanced product quality, ease of scalability, greater process robustness, cost reductions, and reduced processing times.
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, implement strategies to build an optimal development and manufacturing organization, effectively communicate your CMC strategy, and efficiently manage your workflow to accelerate development of your products.
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.
Pharmefex supports all of your quality and CMC regulatory requirements through the design and implementation of quality systems appropriate for the stage of your product. We can prepare and review standard operating procedures, phase-appropriate product specifications, and process or method qualification protocols. We also review batch records for all GMP-driven operations, including drug substance and drug product manufacturing. We specialize in writing, reviewing and negotiating Quality Agreements with your contractor(s) to ensure that they are comprehensive and protect your investment.
Whether you are using Quality Risk Managment as part of your overall development strategy, or using the various tools and techniques to identify your CQA's, prioritize your studies, conduct root cause investigations, or improve the effectiveness and efficiency of your processes, Pharmefex has the expertise to help you from start to finish. Why take a risk when it comes to risk management? Contact us today to find out how we can help you.
Pharmefex offers comprehensive and dynamic project planning and management services to keep your development and commercialization programs on time and within budget. Our team can help you integrate all of your product development requirements into comprehensive playbooks that provide seamless roadmaps for efficient management of your product development programs from the initial identification of a new product candidate through clinical trials and commercialization.