WFC specialises in regulatory affairs, assisting you to secure your required regulatory approvals promptly and with the minimum of difficulty.
Our services are flexible and designed to meet the bespoke needs of our clients. Whether you are an SME developing a new drug, device or other research project requiring full regulatory affairs support, a larger organisation seeking to outsource aspects of regulatory affairs, or an academic seeking support to develop and finance your research proposal, the WFC team can help.
Our aim is to enable research projects to initiate as rapidly as possible. When working with WFC a dedicated consultant will become your ‘caseworker’ and look after your entire application, initiation of sites and set-up, ensuring a streamlined process.
Protocol and documentation development
WFC will assist you to develop your research proposal into a full protocol with associated documentation ready for regulatory review. This can include statistical advice to ensure appropriate power calculations and a robust design.
We have access to expert pharmacy and imaging associates who can provide the required guidance and recommendations for your research project.
Regulatory affairs and submissions
We provide expert advice on the regulatory requirements for clinical research in the UK and internationally and are able to populate all required forms and make submissions to the relevant regulatory review bodies (both ethical committes and Competent Authority).
WFC can provide continued regulatory affairs support throughout the project lifecycle, managing any amendments and reporting requirements to relevant bodies.
Site selection and initiation
We can assist with the identification and selection of suitable sites and develop innovative recruitment strategies. In addition, WFC are able to manage the entire site initiation process, negotiating contracts and contracts, and working with sites, to ensure a rapid set-up process.
Monitoring and compliance
We are able to implement monitoring plans to ensure on-going compliance at both central and site level, producing monitoring reports and working with research teams to deliver all required corrective and preventative actions.
Preparing teams for regulatory inspection
If your organisation is about to undergo a regulatory inspection from a Competent Authority (CA) such as the Medicines and Healthcare products Regulatory Agency (MHRA) or international variant, or from a regulator such as the Human Tissue Authority (HTA) our team of experienced staff can support you and your research teams to be inspection ready. We provide support and training on how to approach a regulatory inspection, can assist with preparatory audit, and arrange interview practice for key staff.
Quality assurance (QA) work-stream projects
We offer a wide range of quality assurance (QA) services including quality management system (QMS) reviews, risk management reviews, phase I accreditation reviews, and computer systems validation (CSV).