The process of managing a regulatory submission is resource- and time-intensive. Documentation is gathered from years of research, spanning multi-disciplinary functions. All these documents and data are sent to various regulatory authorities, each of which have specific requirements and ongoing demands for more detailed information – further adding to the burdens regulatory departments face.
By Usha Sharp, Senior Professional, Regulatory Engagement Management, CSC
Even after being granted marketing authorization, the work involved in managing the life cycle of the product remains intense as regulatory departments must contend with constant updates, such as changes to company information, the manufacturing process or the use of excipients. Regulatory departments must also stay abreast of country-specific requirements and interact regularly with the authorities.
All these activities take time, they take knowledge, and they take relationship-building capabilities.
The Role of a Submission Manager
Working with a business process services (BPS) partner opens the door to an important and invaluable relationship with a submission manager, who becomes your single point of contact in the submission process.
By removing the layers and complexity of working with multiple points of contact, and establishing one-to-one relationships, your life is made much easier. You can work with one person who has the knowledge and expertise you require, who can simplify the process, and with whom you can build a trusted relationship. That person manages all day-to-day activities, controls workflow, and plans and coordinates project milestones and deliverables with submission team members, thereby ensuring timelines are met.
Your submission manager helps you with all aspects of the submission, facilitating compliant, high-quality and timely submissions to the health authorities, and ensuring that final deliverables meet current regulatory requirements and guidances.
This support spans all submission types, including the electronic common technical document format (eCTD) and non-eCTD electronic submission format (NeeS), and irrespective of the regulatory authority: the European Medicines Agency, the US Food and Drug Administration, and beyond.
Some agencies still require paper or CD/DVDs, and your submission manager can support all those expectations.
Beyond simply ensuring submissions comply with the regulations, a good submissions manager has knowledge of the intricacies required by each authority and any changes that the regulators have introduced, as well as how those changes will impact tools and processes.
In addition, your submission manager can assist with administrative tasks, including resource management, project setup and invoicing, as well as facilitate client meetings and document all meeting outcomes when necessary.
Your submission manager can also closely monitor progress of assigned projects, documenting all issues and correspondence. They will ensure follow-through by communicating issues and relaying resolutions to all appropriate staff and support you with oversight of tracking sheets, metadata, issue logs and management of files. They also can ensure that the naming of files is in accordance with ICH and regional requirements as well as client specifications.
All aspects of the submission, such as file names and the structure of the submission must be valid, and your submission manager is there to carefully review validation reports, making sure any issues are fixed before providing final output of the submission.
The Wider Picture
While your submission manager is your daily point of contact, behind that person is a whole team of experts who can support your submission activities. This team generally brings:
- A wide range of experiences from having worked on multiple projects with numerous life sciences companies
- In-depth knowledge of systems and tools required to support the submission
- Support in the form of a back-up submission manager, who can step in and cover a project as required, for example during sick leave or holiday cover
- Global support and expertise, with backup across multiple time zones
Your submission manager also works closely with submission publishing teams; managing and overseeing all activities, and may also work with various functions across your business, including non-clinical, data management, CMC (chemistry, manufacturing, and controls), data management, pharmacovigilance, medical writers and project management. Their purpose is to make sure the submission plan is accurate and that it achieves milestones and timelines.
Having a single partner to lead you on your submission journey, in the form of a submission manager, will ensure your questions are responded to rapidly, your submissions are thoroughly and thoughtfully managed and that all processes are streamlined.
View our recent webinar, “Business Process Services – A Strategic Enabler for High Quality Regulatory Submissions.”