Established in 2001, Capital K Consulting (formerly Stringer Consulting) is a leader in the provision of regulatory, market access and clinical services to the Australian and New Zealand region. Capital K's Directors and senior consulting team each have 20 years' or more experience in the prescription, OTC and generic pharmaceutical sectors and while Regulatory Affairs forms the backbone of this experience, all staff have held multiple roles in the industry, together covering all key disciplines including marketing, quality assurance, manufacturing, pharmacovigilance, clinical research, strategic planning and business development. This whole company view, and the application of our expertise to all client projects, is one of the key drivers of Capital K's success in achieving excellent business outcomes for our clients, and a primary point of differentiation from our competitors. At the core of our philosophy is the adoption of a commercial approach to all market access activities. Our deep understanding of the critical inter-dependencies between data, registration, reimbursement and commercialisation enables us to deliver innovative technical strategies to maximise commercial potential.
Our recent joint venture with Doug Kentwell from Regulatory Solutions has further enhanced our service offerings to include industry leadership in overturning and avoiding adverse regulatory and administrative outcomes via the various appeal mechanisms.
Robert (B.Pharm. (Hons)) is the Managing Director at Capital K and oversees all consulting activities. Robert has more than 20 years of experience in the Australian and New Zealand Pharmaceutical industry. Prior to establishing Capital K Consulting, Robert was a part of the leadership team at AstraZeneca Australia, having managed the Regulatory Affairs, Clinical Research and Strategic Planning & Business Development teams. His career also includes the green fields market entry for Sandoz (the generic arm of Novartis) in Australia, ultimately holding the role of Research and Development Manager, where his responsibilities included leading the regulatory, product development, and quality assurance functions, along with joint leadership of the product sourcing and partnering arrangements. While at Sandoz Robert was instrumental in achieving the world-first regulated market approval of a biosimilar product. In addition to overseeing all Capital K consulting activities, Robert takes the lead on high level regulatory strategy activities (including appeals), and all organisational development, market access, biosimilar projects and appeals.
Nancy (B.Pharm. Dip. Hosp. Pharm.) is the Director of Consulting and leads the Regulatory Affairs team. Nancy has worked in the Australian and New Zealand Pharmaceutical industry for more than 20 years, both as an employee and as a consultant, providing regulatory and commercial support for more than 30 companies. During this time, Nancy has prepared, submitted and evaluated innumerable applications and achieved significant approvals for prescription new chemical entities, biological medicines, and various OTC medicines. Having worked in marketing as a product manager and in various technical and regulatory roles, Nancy has a passion for creating and developing commercial opportunities for local regulatory files. At Capital K, Nancy oversees all regulatory affairs projects, manages the regulatory affairs team and can provide expert, customised training, support and guidance to client staff on all aspects of Regulatory Affairs.
Doug Kentwell, our Principal Consultant and project lead for all regulatory and administrative appeals activities has more than 30 years direct senior experience in the Australian federal health and welfare sectors. He is widely acknowledged and respected as a leading authority on Australian machinery of government, especially therapeutic product regulation, having played a key role in the development and implementation of the Therapeutic Goods Act 1989. Throughout his career Doug has managed more than 170 regulatory and administrative appeals, with a success rate of over 80%.
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