Q.In what therapeutic areas does Capital K have experience?
A.The team at Capital K has worked in almost all therapeutic areas, including the more specialised areas of oncology, biotechnology and respiratory medicine. As Nancy and Robert are registered Australian pharmacists and all senior consultants have 20 years+ experience in the industry, we are confident we can apply our knowledge to all areas of prescription and OTC medicines.
Q.Can Capital K provide in-house support for clients?
A.Capital K offers "outsourced" and "insourced" support options for clients, depending on staff availability.
Q.Do you provide support for OTC and complementary products?
A.Registration applications for evaluated OTC pharmaceuticals are one of Capital K's key strengths. We also provide some support for listed OTC and complementary medicines although this is not a core business focus. Should your needs fall beyond Capital K's core OTC areas, we can put you in touch with our strategic partners that specialise in complementary medicines.
Q.What support can Capital K provide for bioavailability and bioequivalence studies?
A.The team at Capital K has extensive experience with bioequivalence through many years working within the generic pharmaceutical sector. Consequently, Capital K can provide guidance on the type of studies needed and the acceptability of existing data. Capital K are the current ARCS Bioavailability and Bioequivalence course facilitators, and can also provide advice to clients on potential centres of excellence for conducting local bridging studies.
Q.What services does Capital K provide for clients seeking reimbursement on the Australian Pharmaceutical Benefits Scheme (PBS)?
A.Capital K provides consulting services to clients on the broad issues surrounding the operation of the PBS and the strategies required to achieve successful PBS reimbursement, including the application of the ongoing initiatives by the Australian government regarding PBS reform. Capital K provides direct support for secretariat listings and minor submissions, and provides advice for major submissions though our specialist reimbursement application partners.
Q.What level of support does Capital K provide for clinical trials?
A.Capital K provides strategic and regulatory support for clinical trials however Capital K is not a Contract Research Organisation (CRO) and does not conduct clinical trials for clients.
Q.Does Capital K provide consulting services for medical devices?
A.While Capital K can provide high level advice on device-related matters, this area is not core business. We maintain a strategic partnership with organisations who focus on device activities so should your needs include medical device support, we can connect you accordingly.
Q.Does Capital K provide pharmacovigilance and RMP services?
A.Capital K provides direct support for the generation and maintenance of Risk Management Plans (RMPs) and Australian-specific Annexes (ASAs) to European RMPs. We can also provide strategic guidance on adverse event responsibilities however for operational adverse event reporting services we utilise our strategic partnership with specialist pharmacovigilance service providers.
Q.How are Capital K service fees structured?
A.Capital K offers a flexible range of billing approaches based on the type of services provided. These fees can range from hourly rate consultancy billing, through to fixed project costs and retainer fees. The best billing approach is generally negotiated with our clients during the project scoping phase.