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We offer a wide variety of services for programs at any stage of development
From writing RFPs to participating in weekly TCs to reviewing reports and documentation. I have experience with vendors on three continents and maintain a matrix of vendor capabilities. My focus is on ensuring positive results while taking a holistic view of costs that includes a vendor’s ability to develop an efficient process and cost of management.
An effective impurity control strategy is crucial to ensuring patient safety and a key focus of regulatory oversight. It is more than a list of acceptance criteria in a specification; it is designed into a process and proven experimentally. I develop and demonstrate impurity control strategies for non-mutagenic impurities, mutagenic impurities, and nitrosamines.
A good development plan is more than a roadmap – it anticipates potential roadblocks and provides room for contingency plans. I take your goals and timeline and assemble a development plan that can make them into a reality.
Writing an effective regulatory submission is about clearly conveying a narrative that answers the question “how does this process guarantee the product’s quality and safety?” I have authored Module 3 leaves for multiple submissions and can help you ensure reviewers will be satisfied with the answer.