Capital K was engaged to assist a pharmaceutical company with overturning a TGA decision to reject a new presentation of a drug-device combination product. The project included identifying and engaging suitable local clinical and technical experts to develop supporting documentation, preparation of the Section 60 and Administrative Appeal Tribunal submissions and coordinating the interactions with the various parties.
Capital K was commissioned as the primary support for a local company seeking to overturn a negative Clinical Evaluation Report and negative Delegate's Overview for a new fixed-dose combination prescription medicine TGA application. Through negotiations with various TGA personnel and the development of compelling clinical and administrative arguments, the product and claims were approved for registration by TGA.
Capital K was appointed to provide local regulatory advice and expertise to a new company commencing supply of 'exempt' medicines under Schedule 5A of the Therapeutic Goods Regulations. This advice provided the company clarity on the legal Australian boundaries for manufacturing, technical documentation and ongoing supply activities for the medicines.