PharmaLex UK is a full service consultancy. Using our wealth of experience we can help guide you through the regulatory process, allocating the best possible resources to ensure successful completion of your project.
Our priority is to ensure you successfully address your key regulatory challenges. Our high quality and varied work enables us to provide you with greater depth of experience and expertise. Regardless of whether we are acting as consultants or providing more hands-on support, it goes without saying that we are focused on outcomes. A positive result for you is a positive result for us.
So regardless of your challenge, we can help address it by finding the most appropriate solutions to assist you to achieve your desired outcome.
More information on our range of services can be found by selecting the relevant section below.
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION
- Regulatory Affairs
- Medical Information
- Strategic Development
- Services A to Z
Regulatory affairs is the practice of ensuring that pharmaceutical products and medical devices are developed and marketed in a manner which is compliant with legislation and reflects traditional advances in scientific and regulatory requirements. Before your medicinal product can be marketed in the EU, you must first obtain a marketing authorisation (licence) from the relevant competent authority.
Balancing the risks and benefits of a medicinal product requires strict testing and assessment for quality, efficacy and safety before it can be authorised. This process also continues post-marketing authorisation, helping to ensure the medicine continues to be safe and effective.
The legislation that governs pharmacovigilance in the EU was revised in 2010 and became applicable in 2012. It is one of the most advanced and comprehensive systems in the world. It now requires that all companies are inspected against strict guidelines and are therefore expected to be fully compliant from the outset…
In the EU it is important to have a well-maintained Medical Information service in place in order to market a medicine.
In addition to making arrangements for the provision of a medical information service, marketing authorisation holders must also maintain a system for managing advertising materials, including their provision to the authorities as requested…
In-licensing and out-licensing provide an important tactic by which companies are able to expand their pipeline and/or can maximise the market opportunity of their products.
Most companies enter into licensing negotiations with partners at some stage. These can relate to in- or out-licensing or local manufacture, distribution or marketing…
Understanding the differences in legislation, national guidelines and medical practice across different countries is essential when planning your regulatory strategy. The way a particular medical condition is managed and the standard therapy used can differ and in turn affect the approach you take.
A key challenge is successfully navigating the regulatory landscape. This information can sometimes be difficult to obtain without access to specialists based within the appropriate area. Sometimes a significant amount of research is needed to determine which comparator or endpoints in a clinical trial will satisfy the requirements of the local regulatory authority. This is particularly true for innovative therapies or for orphan indications…
Wainwright Associates can provide you with bespoke solutions to address any challenge. We have experience in a broad range of areas – from prescription medicines, OTCs, herbals and homeopathics, to biological projects and medical devices.
Our extensive global network allows us to give you the most appropriate support and guidance. So whatever your requirement, we have the right experience to help you…