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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. It involves regular monitoring of legislation for any changes which may affect a company’s products or their development in different geographical regions. A key concern for pharmaceutical companies today, is that drugs or devices which are manufactured in one country, are able to meet the regulatory requirements of another. Regulatory affairs professionals not only ensure proper records management and appropriate data presentation but undertake all necessary communication with the regulatory agencies to ensure compliance and quality standards are maintained. The key benefit is the impact it can have on a pharmaceutical company’s economic growth. Using professional regulatory experts can maximise your label claims and help ensure that no delays are encountered, for example in getting a product or device through preclinical and clinical stages 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 a more in-depth knowledge of the regulatory environment. Through our experience, we have enabled our clients to obtain approval in the regulatory environment. 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 compliance. We also understand that being able to work within your internal system and processes is of utmost importance. We are able to seamlessly integrate 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.REQUEST MORE INFORMATION