SP Formulations has partnerships with US and European manufacturers for the production of clinical trial materials. Materials will be produced according to cGMP requirements as appropriate for the clinical stage of development.
We can meet a broad range of requirements, from small pre-clinical and clinical batches to commercial scale production. With an experienced team of professionals, we offer conventional formulation development as well as novel approaches to drugs that are difficult to formulate.
Our regulatory group and our quality assurance staff will work with your team to ensure that the results are acceptable to both you and the appropriate regulatory authorities. Our Qualified Person (QP) for Europe is able to release all necessary batches for use within the EU.
