Capital K was commissioned by a venture capital company to prepare a regulatory due diligence report to assist in their investment advice for a potential new prescription medicine. The report scoped the current and future medicine regulatory environment as well as the available medicine data, and provided appropriate insight into the clinical development process, timing and critical success factors for market entry in Australia, Europe and the USA.
Capital K was engaged by an international strategic consulting firm to address a series of queries regarding a portfolio of Australian prescription and OTC medicines. The questions probed the current and future regulatory paradigm for these products, consideration of potential therapeutic developments, and identification of specific critical market access factors for new competitors.
Capital K was approached by a start-up company to review the currently available technical data for a new prescription medicine and provide strategic advice as to the pharmaceutical development and non-clinical data requirements in order to progress the product into the clinical trials phase. Capital K provided advice and overall regulatory parameters for the medicine in Australia, Europe and the USA, and continues to ensure the early phase clinical development is aligned with the regulatory and marketing strategy.