PharmaLex UK Services Limited

Regulatory affairs is the practice of ensuring that pharmaceutical products and medical devices are developed and marketed in a manner which is in accordance with legislation and reflects 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. The processes to achieve this are varied and complex, and may depend on, for example, the type of product, the therapeutic area and your commercial objectives. Once a marketing authorisation is achieved, it must be maintained to reflect changes in manufacturing or risk benefit and take account of changing legislation. The role of a regulatory affairs professional is not only to ensure proper records management and appropriate data presentation but undertake all necessary communication with the regulatory agencies to ensure the relevant requirements and quality standards are maintained. Using professional regulatory experts can maximise your label claims and help ensure that no delays are encountered in getting a product through the authorisation process and onto the market.

How can we help?

Our consultants are experts in the steps that should be followed and the development pathways that may be required to advance products that fall within pharmaceuticals or medical devices or find themselves on the borderline. The nature and variety of projects we undertake for clients gives us an in-depth knowledge of the regulatory environment. Through our experience, we have enabled our clients to obtain the necessary approvals. Clients have also sought our expertise to appeal against negative opinions from regulatory authorities or when faced with referral procedures. With our innovative regulatory thinking and scientific rigour, we have established a reputation for trouble-shooting and promoting successful outcomes.

We strongly believe that a forward thinking approach, bringing regulatory competencies into all parts of your business can help promote competitive advantage as well as a successful regulatory approval. We also understand that being able to work within your internal system and processes is of utmost importance. We are able to integrate seamlessly with your existing workflow, so whether you need support with routine regulatory requirements or have a more complex or challenging project, we have the necessary expertise to support you to achieve a positive outcome.

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.

Wessex House Marlow Road Bourne End SL8 5SP United Kingdom