Emerging Biotech Improves Submission Timelines with Continuous Publishing

With several innovative therapies in the pipeline, one CAR T-cell therapy company is at a pivotal point in its regulatory journey. Having achieved FDA approval for one of its products in the US, the company also has several pipeline assets.

Managing regulatory information across multiple markets demands perfect alignment of speed and transparency — a challenge for many biotechs. “Everyone wants to go as fast as possible,” says a regulatory operations lead at the company. “But being in several regions makes speed sometimes a challenge.”

By unifying its regulatory information management (RIM) systems with Veeva RIM, the biotech company streamlined its submissions approach across multiple regions. A key piece of the puzzle was introducing continuous publishing: “We always aimed to manage the BLA submission in-house. Having a tool in place gave us time to publish submissions ahead of the BLA,” explains the regulatory operations lead. “For the BLA submission specifically, it enabled us to file faster. It’s very important for the company to have that speed,” they add.

Simplify workstreams with parallel authoring and publishing

Biotech companies that begin the publishing process early can initiate validation at the same time, streamlining and accelerating the submission process.

With Veeva Submissions and Submissions Archive already in place, the regulatory operations team increased the value of the unified Veeva RIM solution by implementing Veeva Submissions Publishing. Switching to in-house continuous publishing, within a rapid three-month timeline, the team optimized preparation for the Biologics License Application (BLA) submission. “Filing for our first drug was our driving force,” recalls the regulatory operations lead. “As soon as a company comes to file for a drug, there’s a keen focus on everyone following one process.”

Continuous publishing and validation, in parallel with the submission document authoring process, enabled publishers to move their tasks upstream. This has reduced late manual rework, validation errors, and bottlenecks. “I knew for a company of our size, Veeva Submissions Publishing would be valuable because we want to go so fast,” explains the regulatory operations lead.

“I knew for a company of our size Veeva RIM would be valuable, because we want to go so fast.” – Regulatory Operations Lead, emerging biotech company

Better collaboration, shorter submission timelines

Previously dependent on fragmented regulatory systems and processes, another key goal was to accelerate submissions by improving collaboration and transparency among regional functions. Teams began reviewing and approving documents within a single trusted platform rather than using various other channels including email, disparate spreadsheets, and storage drives. “Having a single source of truth is every company’s ambition,” says the regulatory operations lead.

A clear and simple onboarding experience facilitated the rapid adoption and use of Veeva Submissions Publishing. “With any other tool, it would be impossible to jump straight into publishing without a lot of training,” the regulatory operations lead notes, adding: “Because of my experience with Submission Content Plans, I could use Veeva Submissions Publishing right away. This is great for resourcing a lean team.”

“Having a single source of truth, that’s every company’s ambition” – Regulatory Operations Lead, emerging biotech company

With real-time visibility and traceability through submission content plans, end-users can see outstanding items and swiftly make document updates to meet tight deadlines. Using continuous publishing in Veeva RIM, the emerging biotech company filed its BLA submission ahead of schedule. “We can get the last document for the FDA at midday and submit it within an hour,” the regulatory operations lead says.

An advanced RIM environment

The company now leverages the Vault crosslinking between Veeva RIM and Veeva Quality, enhancing agility and control. “It means we can answer queries straight away without having to download and re-upload documents,” the regulatory operations lead explains.

The company implemented Veeva Registrations in August 2024 and intends to use this application to scale its management of ever-increasing volumes of xEVMPD and IDMP registration data.

Future of RIM transformation

A unified RIM solution that includes continuous publishing has increased the biotech company’s regional drug application submission speed and efficiency.

Veeva RIM’s feature releases three times a year adds continuous value to the regulatory operations team: “One thing I like about [the platform] is that it continues to develop. The applications don’t ever just sit there. They evolve with industry standards, but also based on customer feedback,” the regulatory operations lead concludes.

“I don’t think we could do without [Veeva RIM]. For the BLA submission specifically, it helped us file our submission faster. It’s very important to the company to have that speed.” – Regulatory Operations Lead, emerging biotech company

This culture of feedback and improvement will support the company in remaining agile in the face of continuous regulatory change.

Learn more about the Veeva RIM end-to-end solution.