As regulatory experts, we are often asked to explain how international drug registration procedures function and why on earth they need to be so incomprehensible and complicated.
What we have learned over the years is that regulatory projects require diligence and attention to detail to see them through to completion. International regulatory projects do generate significant workload at certain predefined points, often within short time periods when a fast response is essential to processing a licence application.
This can only be addressed with experienced and well resourced internationall teams who use sophisticated communication tools and techniques to facilitate the management of the projects.
Since 1994, we have been assisting clients with all types of projects to help then increase “speed to market” of their products.
In 2001 we established an international network of regulatory experts (www.regulanet.com) throughout the world and developed a quality driven system to ensure immediate world-wide communication and flow of information and data. We offer advice on development and regulatory strategy and, dependening on the project, we can do some or all of the development and regulatory work ourselves or we can provide a project management service to assist the client.
We have worked successfully with some of the very largest (and smallest) national and international pharmaceutical companies, and our skilled and flexible workforce allows us to undertake both large and small projects.