Selecting the right electronic submission services vendor for your organization’s 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 boast a less formal, less structured process. 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 here. Let’s look at this checklist and how working with a strong vendor will best support your needs.
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 Synchrogenix has published more than 6.2 million pages 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 Synchrogenix’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 Synchrogenix supports for your needs now and in the long term.
Reliability and trust / Team with deep knowledge and expertise (strong credentials) / Specialized consulting and regulatory expertise
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 Synchrogenix has created efficiencies in publishing and the submission process for its clients where they hadn’t existed before and helped those clients meet timelines they would have otherwise struggled to meet. You can read regulatory success stories here.
The 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, where our clients can 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 this dedicated team.
Round-the-clock publishing support, including global operations / 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 a vendor, it is imperative that the vendor can seamlessly move your project forward.
Certara Synchrogenix’s global resources in the US, Europe, and Asia scale up or down as needed to support a submission, making it possible to work around even the most challenging of deadlines. The team has proven capacity for growth as we continue to expand our Regulatory Operations team and its technology each year adapt to a changing 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 the greatest ease at the onset of a project. Certara Synchrogenix’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 allow jobs to get done more quickly and 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 its internal team and client groups, provides your regulatory operations team the eCTD software they need to efficiently publish, validate, and review regulatory submissions. PUBLISH, VALIDATE, and WebReview ensure compliance, technical validity, and timely review of all of submission components.
Efficient/speedy onboarding process / Availability of user support, training, and on‑boarding
When it’s time to start, it’s time to start! Selecting a vendor that can smoothly on-board and ramp-up quickly could make the difference between missing and meeting a regulatory submission deadline. Certara Synchrogenix’s well-documented software training program and first‑class customer support service are some of the perks that come with working with a team of experts and the technology to get the job done right.
Support of multiple eCTD jurisdictions / 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 Synchrogenix’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, and Japan PMDA.
Strong user authentication and advanced security
It is 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 projects, including Advanced Encryption Standard (AES-256) encryption for data at rest and at transfer.
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. Utilizing a vendor evaluation checklist will help you identify the provider with the right people, best procedures, and most efficient tools/technology to get the job done.
Download the checklist here.
For customized submission support that accelerates and anticipates, consider Certara Synchrogenix. Learn more about our regulatory operations and eCTD publishing services.