Getting your product’s regulatory submission ready to send to the FDA, Health Canada, or European health authorities can be time-consuming and challenging, but it doesn’t have to be. A good submission publishing and management partner can help you address this daunting task with proficiency and efficiency.
Even with the emergence of electronic Common Technical Document (eCTD) submissions, there are still companies that provide publishing and management services for eCTD submissions that may not be completely up to speed on the requirements of the eCTD format. We have compiled some of the key considerations when evaluating eCTD submission vendors that you should keep in mind as you search for a partner to work with during your next regulatory submission cycle.
Can the vendor demonstrate their knowledge and experience producing eCTD submissions?
Consideration #1 for evaluating an eCTD submission publisher is their experience in electronic regulatory submissions, particularly their experience with producing, compiling, publishing, and managing a submission lifecycle. How many submissions have they done? How experienced is their team? You should be able to get a sense of their practical knowledge prior to signing a contract.
Are they experienced enough to offer options to challenges?
We’ll take the experience question a step forward. When evaluating an eCTD submission publishing and management vendor, it is important to consider whether the vendor is experienced enough to offer solutions to regulatory operations and submission management challenges. In order for an eCTD submission partner to be successful in helping their customers meet regulatory requirements, they must have a deep understanding of regulatory operations and the submission management processes. When an issue arises (they always do), the partner should be able to troubleshoot issues and propose viable solutions based on their previous experience. They should also be able to provide guidance to their customers on how to implement effective strategies to avoid potential bottlenecks or other issues.
The vendor should be well-versed in the latest regulatory guidance and technological advances. This will ensure that their deliverables are up-to-date and adhere to all applicable regulations. Additionally, the vendor should have experience working with different types of regulatory bodies, so that they can adapt their deliverables for a specific region.
By digging into their practical experience, you can ensure that you are working with a capable eCTD submission vendor who can navigate issues and won’t leave you scrambling to find support.
Does your eCTD vendor have references from customers that are similar in size to your organization?
It is important to check the references of any submission management and publishing vendor that you are evaluating. You should understand how they interact with clients once a contract has been signed. It is also important to understand how often they work with similarly sized teams.
In many cases, they will become your regulatory operations team or will be augmenting your current team and working very closely with them. If you have a small team, you want to make sure you won't get lost among larger accounts and possibly be put in the position of being a lower-priority client. When checking references, ask specific questions about the types and frequency of interactions. Good communication is important to the success of your submission, no matter the size of your team. If you have a Reg Ops team, make sure to seek out and include them in the evaluation process. Regardless of how small they are, they will be the most impacted by the vendor you choose.
How responsive is the eCTD submission vendor to last-minute changes?
When checking references, ask about the potential vendor's service levels and how responsive they are to last-minute changes. The development and finalization of regulatory submission content is often a complex process that requires numerous approvals prior to submission. Quite often, portions of the content are finalized as other parts of the submission are being compiled and published. Discrepancies happen as multiple authors start to bring their content together within the submission structure. These frequently result in late-stage changes and updates to submission documents.
These scenarios are bound to happen. It is the nature of the business, and your submission management partner should be familiar with these constraints. Regulatory submission deadlines are typically critical for the organization to maintain compliance or to reach an important milestone. Your submission management partner should understand and appreciate the need for flexibility and efficiency.
The submission partner should also be able to alleviate some of the stress in these scenarios by offering eCTD publishing strategies that allow the team to make progress toward the finalization of the submission while some components are still being reviewed or modified. Seasoned regulatory operations professionals are creative and understand the dependencies among documents and the implications of "publishing at risk."
Does the vendor offer any unique value that other vendors don't offer?
As you narrow down your choices for a publishing partner, you should understand the vendor's focus, specializations, and any relevant partnerships they may have. Are they a small or large team? Will they be able to offer the services and focus you demand? Are their regulatory services important within their business model, or are they an ancillary or add-on service that may not be core to their business model? For example, some software vendors offer regulatory services. You need to make sure that the people submitting your regulatory submission are not just IT savvy, but also bring regulatory expertise to the table.
Regulatory submissions require nonclinical, clinical, and CMC content (documents) as well as CDISC-compliant data. If you need assistance in any of these areas, your chosen vendor should be able to point you toward an equally experienced partner in these other critical domains.
Do you want to work with them?
Finally, it is essential that you meet the vendor team and understand who will be working with you. Sometimes the subject matter expert that you meet during the sales cycle is much more qualified and experienced than the team you end up engaging. Assess the team's experience and knowledge, but also consider if they are a good fit from a culture perspective. Do you want to work with them? Will they support your organization's goals? Can you interact with them easily? If you have a question, can you easily talk through options and potential strategies?
Communication, responsiveness, and empathy may be considered softer skills but are so important when you are evaluating vendors for a mission-critical activity that has such tight deadlines. You're going to rely heavily on this partner over the life of your submission. You need a competent partner who is a good “fit” for your team.
Finally, your partner should be able to provide robust training to educate your staff about submission requirements and guidelines as well as compliance obligations. It’s imperative that you find a partner that can work within multiple regulatory frameworks, not just one that does what’s asked of them without understanding the bigger picture.
A successful partnership
A successful submission partnership requires skilled people designing and implementing the right tools and processes to deliver consistent and compliant submission output. This requires constant communication, critical thinking and action, and trust. A qualified vendor will understand the complexities, criticality, and strategic importance of a regulatory submission. They will align with your goals and invest in the capabilities, capacity, and, most importantly, the trusted relationship required to be a successful submission partner.
If you are considering outsourcing submission management activities, please contact WAYS to learn how we partner with teams to help them achieve submission success.