For 17 years, we have managed projects on behalf of our clients. These include small ad hoc projects, high throughput work, large extensive projects involving the development and registration of innovative medicines across multiple markets.
Our unique value add is that we have built and continue to build strong, long lasting relationships with our clients. These relationships are based on trust and proving ourselves in achieving (and exceeding) the desired outcome.
We are here for you - to support, to lead, and to always add value. We guide you through the numerous and sometimes complex requirements involved in getting medicine to patients who need it most. You can see our team’s capabilities below, this is not an exhaustive list, but rather a taste of the value we can add to your organisation. Our team members each have 10-20 years' experience in the industry.
A team of specialists holding significant expertise in the pharmaceutical industry with backgrounds in:
A team with diverse and deep experiences for clients to draw on. We have experience managing clinical trials and pharmacovigilance.
Our team is experienced in setting up and running clinical trials. We can also advise and support you through the requirements for BA/BE studies, efficiently so no time or money is wasted.
A team of device specialists who have worked on medical devices/IVDs for small and medium device innovator companies, with consistent success.
We develop pharmaceutical products from bench through to registration and market launch. We are trusted partners for many companies ranging from major multinational organisations to smaller start-up companies.
We work closely with you, adding value to your product development process and achieving the best outcome for your new product pipeline. Our experienced team can support you with product development and registration across numerous areas, including:
We listen so that we fully understand your strategic goals and provide unique and valuable support in the following areas:
Strategies involving innovative/accelerated evaluations, including but not limited to:
We also offer support for complete post approval life cycle management, integration work (following mergers/acquisitions), supply management, recalls management, compliance and high throughput projects, and project management across all projects.
Advice on accelerated pathways/designations:
We provide support from initial application form submission through to approval including:
We provide complete life cycle management support to maintain compliance and maximise the value of your product and product families including:
In Australia, the TGA process for literature based submissions (in place of, or in addition to clinical trials) is quite unique and requires discussion with and approvals from the TGA before submission of your application. We can support and navigate your application through this process.
We are highly experienced at responses to expert advisory committees and can support and guide you through this process.
We provide support with pharmacovigilance activities ensuring you meet your regulatory obligations, including: