Objective, impartial advice tailored to your needs
- We are one of the few last independent, private, family-owned business solely focused on giving pharmaceutical companies objective, impartial advice on how to accelerate patient access to important medical therapies.
- We offer our clients cost-effective and realistic solutions encompassing science, medicine regulation and reimbursement considerations to optimise development timelines. We have supported the development of the regulatory and reimbursement systems in place today.
- We have no clinical research operations and therefore we have no interest in driving unnecessary clinical research cost – we only focus on what you need and what is required by regulators and payers.
Help cut your development costs
We are a small team of experienced consultants but we are also able to rapidly expand as needed, based on our large network of trusted experts whom we have worked with since 2009. Thanks to this business model, we can offer very competitive prices to our clients, while maintaining high quality standards.
Additionally, by leveraging our experience in the European markets we can rapidly identify development paths that satisfy regulatory expectations with the lowest cost. Our interaction with Regulatory Agencies has often led to creative paths to approval, by choosing the right clinical program with the right end-points, taking all regulatory and payer requirements into account. This approach saves you vast amounts of money. We focus on helping you to showcase your new medicine in the best light to the ultimate benefit of patients.
Help reduce your time to market
We take an independent view of your product development and advise on what needs improving, amending or shaping. We’ll steer you on what the regulators are looking for, how to best present your data, how to prepare your submission and documentation, and at the same time you will gain an understanding of what the payers and HTA bodies require.
You’ll get a clear path and direct guidelines from an independent and trusted source. Together, this will optimise your development activities and help you focus on what’s needed to get your drug approved and ready to be marketed faster.
Keep your drug on the market
Once on the market, you need to keep tracking and monitoring the safety and efficacy of your drug, prepare for potential audits and reviews and maintain your product through variations, label changes, etc.
We can support you in building this post-marketing requirements in your development plans, or work with your post authorisation plans to keep your drug on the market with minimal process and cost.