Global drug development consultancy Boyds has bolstered its service offering with the launch of a new in-house regulatory operations service that will enable the company to support the full lifecycle of its clients’ drug development projects.
The new service, which has been developed in direct response to growing client demand, will involve the planning, coordination, and execution of all tasks relating to the development, submission, and maintenance of regulatory documents necessary for the approval and post-approval lifecycle of drugs, medical devices, and other healthcare products.
To lead the publishing division, Boyds has appointed experienced regulatory operations and publishing professional Michelle Hackney, who will support the Regulatory Operations team headed up by Vice President and Head of US Regulatory Affairs, Katy Rudnick.
Boyds has also invested in industry-leading regulatory information management software, LORENZ docuBridge, which provides a range of features including regulatory document management, content validation, and deployment of electronic submissions.
“Regulatory operations play a crucial role in helping companies to navigate complex regulatory landscapes, ensuring products and services meet the required standards of safety, efficacy, and quality, whilst adhering to regional-specific laws and guidelines.” Katy Rudnick explains. “It is a highly complex and often arduous process. By bringing this expertise in-house, we can support the project submissions independently as well as from a lifecycle perspective for our clients and by creating operational efficiencies by reducing associated time and costs. The publishing strategy and timelines are managed internally by one integrated team that combines significant eCTD global publishing knowledge with regulatory submissions expertise to provide an efficient and specialist service. Boyds’ dedicated and expert regulatory team works directly with clients all the way through the drug development process, so bringing in regulatory operations is a natural progression in terms of the services we offer and is in line with Boyds’ ongoing growth strategy.”