Robben Consulting

We have experienced technical leaders and scientists to support any dosage form development but we pride ourselves on our capabilities in sterile product development and commercial support. Our experience includes formulation development and product manufacturing optimization and validation. Characterization of formulations, establishing and suppor... ting drug substance and drug product stability and study of the formulation through the manufacturing chain are all part of creating a high quality product that meets health authority, physician and most importantly patient needs. While doing it right early can lead to a rapid development process, our ability to deal with unknowns impurities, particulate and other issues is what makes Robben Consulting stand out from the crowd. Robben Consulting can help you with: CMC strategies for meeting regulatory authority requirements. Project Team Leadership for CMC activities. Project team activities ranging from formulation development, analytical method development, specification justification, product use studies and manufacturing process development/optimization/validation and Quality by Design (QbD) risk assessments. Crossover device development and characterization of critical to function parameters which are the basis of any device control strategies and design history file points of emphasis. Due diligence activities related to CMC activities including reviews of patent positions, product validation packages, production change controls and production history. Robben Consulting is a division of CEK Enterprises, LLC Web Hosting by iPageRead More