Services

Whether you plan to launch a completely new product, register a generic or plan to parallel import, we can offer professional guidance on the strategies involved in bringing a product through the stages of development and towards launch. We also offer strategic advice for existing products that require involved maintenance or compliance work.

IPC´s main expertise is in project management and we aim to cater for regulatory projects of all sizes. As with the majority of projects, it is very important to carefully monitor their progress and provide the required feedback to the sponsor. We are available to do this every step of the way, whatever the size of the project.

With such a vast amount of options available the process of making a new application can become quite daunting. We at IPC can offer support and guidance in all aspects of dossier writing, compilation and submission, as well as providing any strategic advice.

This new service is available following our recent partnership with the company PIL2005. Full information on the available services can be found at www.PIL2005.com. We use our regulatory expertise in the design, review and sign-off for PILs, and our knowledge of the legislation to ensure PIL2005 remain at the forefront of user testing in both the UK and rest of Europe.

Due to increasing workloads and growth of product portfolios, product maintenance can begin to take up a high percentage of a regulatory professional´s time. We can offer our services to ease this burden, whether this is in the form of day-to-day product licence maintenance, or a more thorough review of several products within your portfolio.

IPC have a detailed knowledge of the regulations involved in Medical Devices and can offer advice and guidance in all aspects. We can advise on strategies, assist in the production of design dossiers, or maintain existing Medical Devices. Please contact us to discuss your needs in more detail.

With experience in the preparation for audits and inspections from various authorities, we can offer guidance and practical support for you. We can assist in the determination and writing of essential procedures for such events.

We can offer training in various areas of Regulatory Affairs, whether this is to a group of new regulatory professionals, or more detailed individual advice or guidance for specific projects. This service is generally carried out on location at your company. In addition, IPC have recently authored a course titled "Pharmaceutical Regulatory Affairs in the EU and US", which is aimed at newcomers to Regulatory Affairs and provides a broad but thorough background to all aspects of Pharmaceutical Regulatory Affairs. Click here for more information on this course.