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Offering provides assistance through the post-approval lifecycle of drugs.
Boyds, a global drug development consultancy, is expanding its service offering with the launch of a new in-house regulatory operations service that will allow 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.Boyds has invested in a branded regulatory information management software, LORENZ docuBridge, which offers regulatory document management, content validation, and deployment of electronic submissions.
The regulatory operations group will be led by Katy Rudnick—the VP and head of US regulatory affairs—with the support of Michelle Hackney and Navila Rehman, who also have a track record in regulatory operations and publishing.
“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, whil[e] adhering to regional-specific laws and guidelines,” says Rudnick. “… The publishing strategy and timelines are managed internally by one integrated team that combines significant [electronic common technical document] eCTD global publishing knowledge