About UsCategory 1 Pharma Consulting opened in July 2015 to assist companies to select, develop and gain marketing approval for their therapeutic products in Australia, New Zealand and other countries.
With significant experience on both sides of the fence, we can work to provide both a commercial and regulator’s perspective on your projects to ensure the best outcome.
With a genuine passion and enthusiasm for the impact pharmaceutical developments can deliver, combined with experience and high-level academic training, we can assist you with a wide variety of projects from simple submissions to complex responses to Agency expert committees.
Dr Tony Whittaker has more than 20 years’ experience in the pharmaceutical industry in senior product development, regulatory affairs and managerial roles with innovative and generic pharma companies, as a senior evaluator at the Australian medicines regulator (the Therapeutic Goods Administration) as well as with a major Australian consulting company.
Dr Whittaker has worked with large and small companies from around the world, including from India, China, EU, the US and Canada to help bring their products to the Australian market. He has worked closely with many large Indian companies and has travelled extensively to India to assist with both product development and regulatory projects.
Deidre Malton is a highly experienced industry professional whose career in the pharmaceutical industry spans over 20 years in regulatory affairs, business development and medical affairs for a range of industry leading employers, the Australian medicines regulator (Therapeutic Goods Administration) and a major Australian consultancy service.
Deidre’s experience includes innovator and generic prescription medicines, over the counter medicines and complementary medicines and has worked with many international companies in the EU, USA, Japan and Asia to register and maintain product licences in Australia and New Zealand.
“Our enthusiasm and genuine passion for the impact pharmaceutical products can deliver, combined with many years’ experience in industry, government and consulting means that we can deliver the optimum commercial outcome for your product, whether that means a simple variation to change a manufacturing site or a complex response to one of TGA’s expert committees.”
Services
Our experience covers the full range of pharmaceutical products, from complementary and registered over the counter products to prescription innovative and generic medicines, including biological products, biosimilars and vaccines.
Development and Regulatory Strategy
There are often a number of ways to do the same job. We can work with you to ensure you obtain the optimum approval in the most time and cost-efficient manner for your OTC and prescription products.
Literature-based Regulatory Submissions
The TGA process for applications based on a literature review rather than sponsor studies is a specific and very formal process. We have the experience to guide your product successfully through the process.
Clinical Trials and Bioavailability studies
These are usually by far the most expensive and time-consuming parts of any development project. With our extensive experience in generic and other products we can review your bioequivalence or clinical strategy to ensure you gain approval for your products without unnecessary studies or expense.
Training
We can provide individual on-site training to staff on pharmaceutical development and regulatory affairs.
Data Gap Analysis
Although many aspects are harmonised, TGA has a number of specific requirements that differ from other markets. We can make sure your data package meets all local up-to-date requirements.
Marketing Applications for Australia and New Zealand
We can take your application for prescription, OTC or complementary medicine from submission to approval, ensuring your product is approved to give the best commercial outcome.
Variations and Life-Cycle Management
Development of a product doesn’t finish with TGA approval. Let us help you to manage your products over their full life-cycle – we can assist with extensions of indication, line extensions and other variations to ensure you make the most of your products post-approval.
Appeals and Responses to Expert Committees
We can prepare responses to Agency questions, appeals under Section 60, as well as responses to TGA expert committees.
Contact Us
We would look forward to talking with you about your development or regulatory projects or challenges.
Please contact us by phone, email or using the contact form.
+ 61 (0) 412 800 845
info@category1pharma.com