Capital K was engaged to support the transfer of production of a parenteral prescription medicine from one contract facility to another. Due to the age of the product, the existing regulatory documentation was incomplete and out of date. The file developed by Capital K was approved without any significant objections from the TGA, and the documentation was also used to support international market product sourcing and variation applications.
Capital K was commissioned by the local affiliate of a global pharmaceutical company to support the TGA submission for a fixed-dose combination of well-established actives. As the product was an OTC medicine developed 30+ years ago, a complete clinical module and supporting scientific justifications needed to be created entirely by Capital K.
Capital K was approached by an Australian startup company to assist with the registration strategy and supporting dossier for a new medicine. The project included a review of the published literature on the medicine class, a critical assessment of relevant scientific guidelines, recommendations on bioavailability study designs, management of bioavailability studies and creation of the pharmaceutical and clinical modules to support the TGA submission and registrations in other jurisdictions internationally.