Regulatory affairs

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 are designed to meet the bespoke needs of our clients. Whether you are an SME developing a new product, 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. WFC can manage your entire application, initiation of sites and set-up, ensuring a streamlined process.

 

Our services:

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.

WFC can provide continued regulatory affairs support throughout the project life cycle, managing any amendments and reporting requirements to relevant bodies.

Site selection and initiation

 

With our in-depth knowledge of the UK healthcare system, 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 produce and implement monitoring plans to ensure on-going compliance at both central and site level.

Preparing teams for regulatory inspection

 

If your organisation is about to undergo a regulatory inspection, WFC can support you and your research teams to be inspection ready.

Quality Assurance (QA) work-stream projects

 

We offer a wide range of QA services, including quality management system (QMS) reviews and risk management reviews.

Contact us to discuss your regulatory requirements