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Regulatory affairs is a profession which ensures that pharmaceutical products and medical devices are developed and marketed in accordance with legislation, reflecting advances in scientific and regulatory requirements. Well-considered regulatory strategies, that take account of the regional and global regulatory landscapes, should be developed to make the most of your product’s intrinsic and designed characteristics, bring your product to market as rapidly as possible and generate data that support your commercial objectives. Effective and timely execution of regulatory strategies requires first-class procedural and publishing knowledge, and accomplished negotiators; whilst marketing approval per se is often the essential objective, the specific terms of the approval and promotional opportunities that follow can make a significant difference to a product’s success in the marketplace. Once a marketing authorisation or CE Mark is achieved, it must be maintained to reflect changes in manufacturing or risk benefit and take account of changing legislation. Forward-looking regulatory strategies will complement this core requirement for regulatory conformance with measures that will proactively advance the value of your product asset throughout its lifecycle, both pre- and post-authorisation. In the increasingly competitive environment, regulatory affairs should be at the heart of responsible innovation.
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 international regulatory requirements. Through our experience and original thinking, we have enabled our clients to obtain approvals and achieve commercial differentiation. We are adept at presenting even the most complex data positively and many clients have also sought our expertise to appeal against negative opinions from regulatory authorities or when faced with referral procedures. Combining this aptitude for innovation with regulatory 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. We also understand that being able to work within your internal system and processes can be important. 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.REQUEST MORE INFORMATION