Literature-Based Regulatory Submission Services - Project Examples

Literature-Based Submission for a New Indication and Route of Administration for a Prescription Medicine

Capital K was commissioned by the local affiliate of a global company to generate the strategy, prepare the submission, and manage to approval a literature-based submission seeking the registration of a new indication and route of administration for a parenteral prescription product. In managing the project, Capital K prepared the literature searches with support from a specialist medical librarian, developed the module 2 documentation in conjunction with local key opinion leaders, and supported the application through to approval. The client company plans to use the dossier to support similar registrations for their international affiliates.


Review of the Literature to Support a New OTC Medicine

Capital K was engaged by a local company to perform a literature search and critical scientific review of the output in order to support a TGA consultation for a new registered OTC medicine. Following review of the literature, Capital K presented our key findings and supported the company to form the registration strategy, which was endorsed following a TGA pre-submission meeting.


Creation of the Clinical Module for an 'N5' OTC Medicine

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, constructed around the available published literature, and supporting scientific justifications needed to be created by Capital K. Through engagement with local key opinion leaders and the company's international resources, a compelling submission was able to be created.


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Literature-Based Regulatory Submission Services