Regulatory Operations Consulting Services
The role of regulatory operations has evolved significantly over the last decade. What was once considered an administrative role is now, a strategic function. However, the role of regulatory operations experts continues to be misunderstood by many of their colleagues in other functional areas.
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What is Regulatory Operations?
Regulatory operations (RegOps) is a support function that is responsible for organizing and managing the flow of regulatory submissions. Regulatory operations professionals are tasked with managing, building, and sending submissions to the regulators in the electronic Common Technical Document (eCTD) format. Furthermore, Reg Ops teams must also ensure the eCTD is compiled in a compliant and validated format before it is submitted.
Regulatory Operations vs. Regulatory Affairs: What’s the Difference?
Regulatory Affairs encompasses the strategic and technical expertise to set regulatory strategy, to prepare and generate regulatory submissions, engage in interactions with regulatory bodies, including both strategic regulatory experience and expertise in functional areas such as chemistry, manufacturing, and controls (CMC), nonclinical, etc.
The Regulatory Operations team is tasked with compiling all of the documents developed by the Regulatory Affairs team into a complete submission in a format that is compliant with the relevant regulatory requirements and confirming that the applicable agency can receive and read the file as it is submitted.
Regulatory Affairs is the content-centered body that makes sure the text and data included in the submission comply with applicable regulatory standards; Reg Ops ensures that the submissions are compliant from a technical perspective.
Strategic Elements of Regulatory Operations
Regulatory Information Management Systems (RIMS) & Process Implementation
One of the key responsibilities of a regulatory operations team is RIMS and process implementation, as it plays a crucial role in ensuring compliance, efficiency, and strategic decision-making.
Before purchasing a RIMS, it is critical that organizations complete the proper due diligence activities. One of the biggest mistakes an organization can make is purchasing a regulatory system prior to developing the process(es) the system is intended to work within. In order for a regulatory system to function optimally, it is important for the processes to drive the systems that are used.
ProPharma’s Regulatory Operations team has extensive experience and expertise in working with organizations to develop processes and select, purchase, and implement the appropriate regulatory systems.
Submission Management
Regulators expect to receive submissions in a very specific format and those applications that are submitted in an organized and easy to navigate manner have a decreased likelihood of information requests. However, the eCTD format was developed with the intention of being a living document, which can make it difficult to keep organized if it is not approached strategically. It is critical that you consider the future state and sequences of the document from the beginning. If this strategic step is skipped initially, you risk the dossier becoming a big headache down the road, potentially creating larger consequences with the regulatory agency later in the process.
ProPharma’s Regulatory Sciences team is made up of the world’s most renowned scientists who are strategic by nature and begin every project with the end in mind. Our team of regulatory operations experts are no exception to this rule, which allows us to anticipate each client’s specific future needs and build the dossier accordingly.
Looking for More Regulatory Services?
ProPharma offers a full suite of services and solutions for all of your Regulatory needs.
ProPharma's Regulatory Operations Services
Electronic Publishing
ProPharma’s team of Regulatory Operations experts has profound experience preparing and submitting regulatory applications in electronic Common Technical Document (eCTD) format for pharmaceutical and biotechnology companies of all sizes.
Our experts have the unique ability to anticipate the future needs of our clients, allowing us to build a submission that is able to evolve and adapt as the product continues through the development lifecycle. We have vast expertise in the following areas:
- Management and organization of CTD files, including regulatory correspondence files
- Quality review of formatted submission-ready documents
- Management of all submission meta-data within the CTD to ensure the regulators are able to navigate the submission and identify file types throughout the application
- Management of all regulatory tools used to ensure compliance with the applicable regulatory body
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