Regulatory Operations and Publishing
Boyds’ in-house regulatory operations and publishing service optimises and streamlines the submission process, helping to bring new medicinal products to patients who need them.
Regulatory operations plays a crucial role in helping companies to navigate the complex regulatory landscape, ensuring products meet the required standards of safety, efficacy and quality while adhering to the stringent regulations and requirements set by global health authorities.
Boyds has an experienced team of regulatory operations and publishing professionals who work with biotech and pharma clients. The team carries out the activities involved in ensuring compliance with regulatory requirements, which include planning, coordination and execution of the tasks relating to the development, technical compliance, submission and maintenance of regulatory documents necessary for the approval and post-approval activities of drugs, medical devices and other healthcare products.
Regulatory operations is a complex and often arduous process. Our dedicated team has extensive experience working with global regulatory authorities, ensuring submissions are accurate, compliant and submitted on time.
Our approach is very personalised and flexible to offer you the best solution to meet your specific regulatory needs. Whether you need assistance with electronic Common Technical Document (eCTD) submissions, the electronic Submissions Gateway (eSG), or any other regulatory documentation, or would like us to manage and oversee the whole process, the team at Boyds is on hand to support you.
The Regulatory Operations team provides you with you the services you need:
- Surveillance of Agency technical requirements for continued compliance
- Submissions management
- Submission-ready compliant documents
- eCTD publishing compilation and technical validation
- Dispatch of submission via electronic gateway
Industry-leading software platform
Boyds has invested in the industry-leading regulatory information management system, LORENZ docuBridge, to enable full electronic submission, publishing, and regulatory document management.
Foreseeing potential hurdles
Our team of expert regulatory operations specialists can draw on their expertise and experience to anticipate potential challenges and hurdles, helping to mitigate the risks of costly delays. Working with the wider regulatory affairs team, we are able to drive greater efficiencies across the authoring, review, and submission steps of the process.
Global agency submissions
As a global company, with offices in the US, UK and Europe, the team at Boyds can support clients with submissions to FDA, MHRA and EMA, and can provide US Agent support, when required, to interact with the FDA on our client’s behalf.
