Services We Offer

Pharmefex  is built on the principle that success in every phase of development requires specialized skills.  We take the time to understand your challenges and provide customized solutions to meet your business objectives whether they are short, focused consultations on specific technical, regulatory, or operational issues or comprehensive management of an entire CMC development program. 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.

Product, Process and Analytical Development 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. (Read More)

Quality and Regulatory 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 (Read More).

Manufacturing Strategy and Operations 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. (Read More).

Outsourcing and Supply Chain Management 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.(Read More)

Program Management 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.  (Read More).