Services

Regulatory Affairs Consulting

With the decline in product development pipelines, the critical role regulatory affairs plays in maximising the medical and commercial impact of all product opportunities is becoming increasingly apparent. At Capital K we believe that the key to a successful regulatory strategy is adopting a commercial approach that targets the broadest, most competitive product attributes that are aligned with the development science and medical positioning. By adopting a perspective of working as an extension of our clients' teams, we are able to accelerate market access, optimise marketplace advantage for our clients and ensure patients receive the maximum clinical outcome. Capital K offers a broad range of regulatory services via in-house and remote support in Australian and New Zealand. These services include registration feasibility/gap analysis assessments, bridging study advice and bioavailability/bioequivalence justifications, registration application preparation, submission and management through to approval, regulatory problem-solving and administrative appeals, RMP and ASA development, indication/claim/labelling reviews, staff training and technical upskilling, as well as general technical consulting across prescription and OTC medicines. Capital K also specialises in Literature-Based Submissions, including medical writing capabilities for the required Module 2 overviews and summaries, and has in-house eCTD and NeeS publishing services.

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Regulatory Affairs Consulting


Re-scheduling / Re-classification Services

As healthcare budgets tighten, many companies are investigating new market access approaches via proactive changes to medicines scheduling. However, successfully achieving medicine re-scheduling or re-classification is a significant challenge, albeit one with immense commercial potential. Capital K has extensive experience in preparing, submitting and managing re-scheduling submissions, having managed a broad range of first-in-class transitions from prescription to pharmacy and pharmacy to general sale applications. Capital K can support clients throughout the process, from the critical step of engaging with stakeholders right through to label development and implementation programmes.

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Re-scheduling / Re-classification Services


Regulatory and Administrative Appeals

From 1 July 2016, Capital K Consulting has exclusively partnered with Doug Kentwell (formerly of Regulatory Solutions) to provide a resolution service for adverse regulatory and administrative outcomes and issues, that is unmatched in Australia. Our team has unique Therapeutic Goods legislation expertise that can identify, guide and fully support our clients through the government regulatory processes, enabling optimisation of the technical and financial outcomes for your business. These services also embrace listing on the Pharmaceutical Benefits Scheme.

In relation to any contentious issue, actual or potential, the preferred strategy will depend on the individual circumstances of each case, but one or more of three broad avenues of redress are usually adopted:

  • Informal strategies – networking within the public service;
  • Formal strategies – utilising available appeal mechanisms and judicial review;
  • Political strategies – direct engagement with the political process.

As these avenues apply across all the regulatory schemes for therapeutic goods, this service is offered to clients with prescription, OTC and complementary medicines, as well as medical device companies.

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Regulatory and Administrative Appeals


Literature-Based Regulatory Submission Services

Many experienced pharmaceutical regulatory professionals understand the challenges in utilising published literature as their key supporting documentation for TGA submissions. However, these bibliographic submissions can represent significant opportunities to open new patient groups, register new formulations, add key text to Product Information and even bring older medicines onto the Australian market for the first time. Capital K has extensive experience in the development and submission of bibliographic applications, with a comprehensive service encompassing development of the initial search strategies, suitable engagement with the regulatory agencies, reviewing and classifying literature search results, assembly of the application and development of overview/summary documents. Through our extensive network amongst the medical and scientific community, we can also provide assistance in identifying and engaging clinical and technical experts to support the applications.

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Literature-Based Regulatory Submission Services


Biosimilar & Biotechnology Medicine Development

The market for biosimilar medicines represents a segment of significant growth within the prescription pharmaceutical arena that is associated with unparalleled development, market access and commercialisation challenges. In this dynamic environment, Capital K is uniquely positioned to provide clients with expert advice on development, registration and commercial strategies, for both generic and innovator companies. In addition to providing strategic market access and technical consulting services in this field, Capital K also offers detailed training courses on biosimilar product development and commercialisation, and regularly makes presentations to various industry organisations.

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Biosimilar & Biotechnology Medicine Development


Due Diligence and Technical Assessment Services

In addition to supporting pharmaceutical companies in achieving market access and driving product development, Capital K also provides due diligence services to medical companies seeking to diversify their portfolios, and to investment/ business consulting firms seeking to understand the highly regulated/technical challenges and opportunities of new medicine ventures. These services range from provision of insight into the pharmaceutical environment and predictions as to overall market trends, through to determination of the commercialisation challenges for medicines in early phase development.

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Due Diligence and Technical Assessment Services


Medical Affairs Services

The traditional pharmaceutical commercialisation model is in a state of flux, with a significant shift in emphasis away from sales and marketing-driven representative calls to one being increasingly led by Medical Advisors and Medical Scientific Liaison, working in partnership with both customers and the commercial teams. This cross-functional approach is at the core of Capital K's philosophy and we offer a range of consulting services to support clients in developing their organisations for success. Typical projects in this sphere encompass development of Key Opinion Leader interactions processes including benchmarking against competitor companies, creation of operational plans for cross-functional market access and medical teams, competitive intelligence analyses, planning and facilitation of tactical and strategic meetings, medical writing for regulatory dossier and clinical trial documentation, pre-market scientific engagement with healthcare professionals, and coordination of war games and other insight gathering activities.

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Medical Affairs Services


Market Access & Product Lifecycle Strategies

At Capital K, we don't see market access as a specific step in product commercialisation, we see it as an overarching strategy for market success, beginning at early product development and continuing through to loss of exclusivity and beyond, where technical product development, regulatory affairs, reimbursement and marketing are key enablers of commercial success. Across this continuum, Capital K offers consulting services to help clients develop products with the attributes and strategies required to accelerate launch timelines, maximise market penetration, and thereby optimise overall commercial return for the full product lifecycle. As part of this service, Capital K can support companies in obtaining reimbursement for their products on the Pharmaceutical Benefits Scheme, through a combination of in-house expertise and our partner networks.

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Market Access & Product Lifecycle Strategies