Quality is the cornerstone of Alphora Research's philosophy, and is incorporated in all aspects of our projects and Client services. Whether you have an NCE being developed for preclinical or clinical phase studies, Alphora's experienced personnel will work with you to build a development and regulatory strategy to ensure success at each stage, and provide the "Right Development at the Right Time" through phase appropriate solutions.
Alphora's experienced team of Quality Assurance personnel are dedicated to ensuring quality is upheld throughout the development process, from project evaluation/planning through the various clinical milestones and validation efforts in advance of market launch. The team's depth of knowledge and experience is not only in quality assurance, but also from working directly in analytical and production environments – experience which allows them to ensure quality from both cGMP and scientific standpoints.
Alphora's developmental data and reports can be used directly by our Clients, as well our regulatory affairs group provides CMC support of your API from pre-clinical through registration.
Alphora maintains a rigorous cGMP system to exceed the industry standards and was successfully inspected and approved by the FDA in late 2008 for a new commercial product.