PharmaLex UK Services Limited

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- YEAR FOUNDED

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.

Pharmacovigilance

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.

How can we help?

Our pharmacovigilance team are experts in quality management and GVP requirements. They will help you set up and run a pharmacovigilance system to ensure you are compliant with the relevant legislation. In addition they are able to conduct audits and provide training to check you are compliant and meeting the necessary standards, as well as providing your internal team with the skills to maintain your pharmacovigilance requirements moving forward.

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.

Medical Information

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.

How can we help?

Our experienced consultants are able to work with you to set up a medical information service that is tailored for your company and products. They can provide you and your customers with evaluated, balanced information and advice on the clinical aspects of medicines using published literature, confidential company data and their wealth of experience. Key services can range from the provision of advice on setting up an in-house medical information function, to a standalone operation of a medical information service on your behalf. Our experts can take calls directly and provide appropriate answers utilising a variety of sources.

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.

Pharmaceutical Licensing

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.

How can we help?

Due to the complexities of the process and subsequent time required to undertake them effectively, it is often more convenient to contract out your in- or out-licensing requirements. Our experienced consultants can help you to locate opportunities and judge the suitability of potential partners and/or products. We can identify the most fruitful leads and provide you with opportunities which have been screened by our experts. We not only have the skills and knowledge of the market to find partner companies but we can also provide full technical assessments of product dossiers for suitability for registration and marketing. A key part of this process is applying the necessary due diligence to ensure the scientific data package is accurate. We provide independent, unbiased assessment reports on all types of products which are invaluable to both licensors and licensees. Data assessments are carried out by discipline experts to the standards of all the major regulatory authorities and will identify areas of weakness or omission in the data and reveal the extent of any further work that will be required. In addition, we can handle all the regulatory aspects of transferring the marketing authorisation to your company.

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.

Pharmaceutical Strategic Development

Understanding the differences in legislation, national guidelines and medical practice across different regions and/or 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.

How can we help?

Our team of consultants have a proven track record of successful regulatory approvals. Coupled with their vast breadth and depth of experience, this enables them to be able to provide you with coherent strategic input when undertaking the necessary research required to devise a development plan for your individual product or therapeutic programme. They can support you by advising on the appropriate regulatory strategy, recommending the best route to the market, drawing up formal project plans with resource allocation, guiding you through study design and protocol preparation, and continually monitoring the project to ensure it stays on track.

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.

Customer On-site Support

Every pharmaceutical company experiences peaks and troughs in workload. A particularly complex, cross-functional and/or multi-national project may require extra resources or specific expertise. Equally you may have a short, medium or long term resource gap which existing FTEs are unable to cover due to maternity/paternity leave, unexpected absenteeism, changes in business priorities, sudden peaks in workload or the advent of unforeseen assignments.

How can we help?

Customer On-site Support (COS) provides a convenient, tailor-made and cost effective solution for companies looking for short-, medium- and long-term resource. It provides complete flexibility, allowing companies to allocate the appropriate level of support to their regulatory, pharmacovigilance and/or scientific affairs teams, as well as ensuring they keep a tight control on the budget. Our experienced consultants will integrate into your company’s team and follow your internal quality system as required, helping to plug key resource gaps. They can cover more long-term requirements such as maternity or paternity leave as well as any personnel shortages. In addition, they can provide specialist expertise for specific projects. The many options include:

  • Full support or dedicated project work
  • Support on an interim basis to replace or extend a client’s own personnel
  • Part or full time support on site at a customer’s premises
  • Range: 1 day per week – 5 days per week
  • Flexibility across the spectrum from less than 1 FTE up to a team of employees requested

Working with PharmaLex UK to meet these requirements brings benefits that other interim resourcing solutions cannot provide:

We recognise that project requirements are rarely linear. Unlike more rigid solutions which require a fixed resource for a limited period, we are able to offer a completely flexible service with the option to scale up or down as requirements change.

With over 450 employees worldwide, we can draw upon significant additional expertise and resource as and when a project requires. We also understand the importance of integrating with your team’s ethos and culture. This extra capability alongside our knowledge of our employees’ experience and personalities, allows us to ensure that we are able to provide a perfect fit for you and your team. Our priority is to make sure our consultants take the weight off your shoulders.

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.

Can we help?