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.

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  1. Appeals & Hearings

    Appeals & Hearings
    Our consultancy services in appeals and hearings cover advice on rejected submissions, assistance in formulating responses, preparations for oral presentations, rehearsals and mock appeals.
  2. Assessment of Scientific Data

    Assessment of Scientific Data
    Our data assessment services facilitate regulatory approvals by identifying potential deficiencies, such that recommendations can be made to resolve them.
  3. Assessment of scientific data

    Assessment of scientific data
    Our assessment of scientific data service facilitates regulatory approvals by highlighting deficiencies so recommendations can be made to resolve them. Our assessment of scientific data is ultimately aimed at producing a technical assessment report that is invaluable for management tools in many situations. For further information about our services please either visit our web site at www.wainwrightassociates.co.uk or call us on 01628 530554 for helpful and friendly advice.
  4. Audits

    Audits
    Our team of inspectors can undertake audits to check for compliance with appropriate quality standards, including GLP, GCP, GMP, ISO 13485 and IS0 9001, as well as pharmacovigilance.
  5. Borderline Products

    Borderline Products
    Our consultants are experienced with borderline products. We can advise which legislation applies.
  6. Clinical Consultancy

    Clinical Consultancy
    Our clinical consultancy services include many areas of clinical research, such as Clinical Trial Authorisations, ethics submissions, pharmacovigilance and GCP audits.
  7. Global Regulatory Intelligence

    Global Regulatory Intelligence
    Our global regulatory intelligence service can identify and advise on local regulations and provide national input into regulatory projects.
  8. Global regulatory intelligence

    Global regulatory intelligence
    Our global regulatory intelligence service can identify and advise on local regulations and provide national input into regulatory projects. For further information about our services please either visit our web site at www.wainwrightassociates.co.uk or call us on 01628 530554 for helpful and friendly advice.
  9. Licensing

    Licensing
    We can help with both in-licensing and out-licensing. Our consultants can begin with a search for licensing opportunities, perform due diligence, assist with negotiations and then handle the transfer of ownership and technology.
  10. Medical Devices

    Medical Devices
    We can provide a range of consultancy services for medical devices including product development, clinical research, regulatory affairs and vigilance