Regulatory Affairs Consulting - Project Examples

Manufacturing Rationalisation

Capital K was appointed by a major pharmaceutical company to provide Australian technical and regulatory support following the closure of a key production site, providing strategic and operational expertise to ensure the smooth and compliant transition of manufacture to a number of new sites. The project spanned an 18-month timeline and involved more than 100 OTC and prescription medicine lines, each with varied production transfer readiness requirements and timelines. Capital K was able to complete the project using a combination of in-house and off-site support, meeting 100% of the assigned production targets and avoiding any stock-out situations for the Australian subsidiary.


Regulatory Strategy Generation and Gap Analysis

Capital K was engaged to perform the technical due diligence of an in-licenced portfolio of therapeutic goods to identify those products that are registrable, to inform and support the Australian commercialization plan. The portfolio review encompassed a critical assessment of the available technical and registration documentation, a high-level assessment of the data gaps and investigation the pathways and broad costs to fill the gaps. This information facilitated a prioritised Australian registration plan and launch list, as well as a range of products for possible further development and associated specialist service providers.


Development of Tailored Operational Tools

Capital K was commissioned by a multinational pharmaceutical company to prepare in-house Australian technical templates, compliant with relevant internal SOPs, and also the latest local and international regulatory guidances. The templates were implemented as corporate compliance tools, and facilitated local operational efficiencies when future global (core) document updates were rolled-out for their medicines.


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Regulatory Affairs Consulting