Choosing an eCTD Submissions Vendor: Your Complete Checklist

Selecting the right electronic submission vendor for regulatory submissions to health authorities for the approval of new drugs or biologics is a critical decision. The vendor selection process varies greatly. Some organizations have rigorous prescribed procedures, while others have less formal, less structured processes in place. Choosing a vendor requires finding a balance between desire/presumption and ability to make things happen. You need to choose a vendor who will help you cross the regulatory submission “finish line.” They must be current on Electronic Common Technical Document (eCTD) requirements and understand the ever‑changing regulatory landscape. Regardless of your organization’s vendor selection process, remember that eCTD is the mainstay for the major global regulatory health agencies.

To aid in your decision-making process, we’ve provided a checklist to help guide your vendor selection process. Download the checklist below. Let’s look at this checklist and see how working with a strong vendor will best support your needs.

What should you look for in an eCTD submission vendor?

✔ Strong company overview, including solid financials

It’s critical to work with a company with market leadership and broad expertise in the industry. This includes sound financial health and a track-record for success, especially in the regulatory operations and submissions space. Our Regulatory Operations team at Certara has published more than 35 million pages since 2018 and supports large and small clients every day with new and maintenance submissions.

✔ Enterprise features, including integrated service offerings

One of the greatest benefits of using a vendor that acts as your “one stop shop” is that you only need to use one! Certara’s Regulatory Operations team is composed of submission experts able to support publishing through technical expertise and consultants able to guide you through the whole process. Teamwork, financial accounting, partnering, and cohesiveness are also important factors that play into enterprise characteristics, all of which Certara can provide, tailored for your needs now and in the long term.

✔ A team with deep knowledge, strong credentials, specialized consulting and regulatory expertise, reliability and trust

When you’re selecting a vendor, look for one with a strong reputation and references that verify its quality. Case studies, testimonials, and clients you can contact as references are all important assets that can direct your decision-making. Certara has created efficiencies in publishing and the submission process for our clients where they hadn’t existed before and helped those clients meet timelines they would have otherwise struggled to meet.

Our Regulatory Operations team has deep expertise in not only the submission process but how to harness technology to support it. Every project lead and team are assigned in continuity, so our clients work with the same lead and same team from start to finish with every new project. Real-world advice on strategy and expertise in your therapeutic area are just some of the perks of working with our dedicated team.

✔ Global publishing support with flexibility and scalability

It’s never easy to conceptualize how you will meet an impending timeline with so many moving parts, as is the case for your eCTD submission. When selecting an eCTD software vendor, it is imperative that the vendor can seamlessly move your project forward.

Certara’s expert resources on the US East Coast, US West Coast, and in the Philippines, scale up or down as needed to support a submission, making it possible to work around even the most challenging of deadlines. The team and our technology have a proven capacity for growth as we continue to adapt each year to a dynamic and evolving industry.

✔ Clear and comprehensive contract/work order

Working under a contract that allows for flexibility, additional considerations, and overall confidence in the project may provide you with the greatest ease at the onset of a project. Certara’s flexible software and services support speaks to the need for flexibility and sureness going into any submission.

✔ Innovative technology and easy-to-use interface

Organizations in the industry are striving to utilize technology that enables work to be completed more quickly, efficiently, and to the highest quality. This technology should save time and improve quality/accuracy while employing a simple user interface.

Certara’s GlobalSubmit software, utilized by our internal team and clients, provides your regulatory operations team with the eCTD software they need to efficiently publish, validate, and review regulatory submissions. GlobalSubmit™

PUBLISH, and REVIEW ensure compliance, technical validity, and timely review of all submission components. Plus, it offers simple single sign-on capability for all users.

✔ Efficient, speedy onboarding process, availability of user support and training

When it’s time to start, it’s time to start! Selecting a vendor that can smoothly onboard and ramp up quickly could make the difference between missing and meeting a regulatory submission deadline. Certara’s well-documented software training program and first‑class customer support service are some of the perks that come with working with our team of experts and the technology to get the job done right.

✔ Support of multiple eCTD regions, and companion templates available

Creating submission-ready regulatory documents that are eCTD-compliant comes with unique challenges. Companion authoring templates act as a springboard to submission success. If your vendor has templates to choose from, this is a huge plus!

Certara’s regulatory teams created our eCTD Authoring Template Suite based on 30+ years of experience planning, writing, editing, and publishing hundreds of global submissions. These templates can be used and re-used to standardize the submission components you may be struggling with. Our software supports the region(s) where you intend to submit, including the US FDA, Health Canada, European Medicines Agency, UK MHRA, Swiss Medic, Australia TGA, Japan PMDA, China, South Africa, and Gulf Coast Council (GCC).

✔ Strong user authentication and advanced security

It’s important that a prospective vendor prioritizes security and can demonstrate its software applications have gone through proper validation and certification. Certara’s GlobalSubmit software is designed to be safe and secure for all your regulatory submission needs.

Summary and next steps

Pharmaceutical and biotech companies continue to rely on vendor use and reliance for eCTD electronic submission, and this reliance is growing. Partnering with the right vendor may be the difference between a successful or failed submission.

To support your decision-making, we’ve created a comprehensive checklist to guide your vendor selection process. Utilizing our vendor evaluation checklist will help you identify the provider with the right people, best procedures, and most efficient tools to get the job done.