Work from our office or on site
Experience with injectable solutions and suspensions and aseptic manufacturing
Data trending, review and CMC writing. Multiple NDA's submitted as eCTD's.
Work from our office or on site
About
Malone Pharma Consulting is a customer-centric organization focused on employing its experience and knowledge to the benefit of its clients. This is achieved by thoroughly understanding your strategic objectives, the project at hand and its associated risks, in order to produce positive results. With over twenty-five years of drug product development and commercial expertise, including the development and launch of five marketed products, Malone Pharma Consulting is a smart choice to ensure that your goals are met as expeditiously and efficiently as possible.
Bob Malone - President and CEO
With a strong technical background (B.S. in Chemistry and M.S. in Analytical Chemistry) and a broad range of CMC experience from phase 1 through commercialization of small molecule pharmaceuticals. Bob brings both a thorough understanding of the big picture and a knowledge of the myriad fine details of product development and quality to bear on your behalf. He has worked in big pharma and headed Quality or Product Development for start ups with a handful of people. Product experience includes inhalation aerosols (oral and nasal, including actuator development and manufacture), inhalation solutions (aseptic blow-fill-seal), injectables, controlled release product, solid orals (tablets and capsules), syrups, eye drops, nasal sprays, oral solutions and suspensions, including combination products. His extensive experience includes also includes supporting drug substance process development and manufacturing, including outsourcing raw material manufacturing.
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