How to choose a regulatory publishing vendor

The five criteria that matter

1. Regions and formats

Confirm the vendor compiles for every market you file in and can handle both eCTD 3.2.2 and the incoming eCTD 4.0, plus NeeS where still required. A vendor locked to one region or one format will slow you down as your pipeline grows.

2. Validation and QA

Ask exactly how a sequence is checked before it ships. A strong answer describes a multi-stage process — a processor build, a QC review against source, a QA final check and a project-manager sign-off — plus technical validation against the applicable specification. B2K runs a four-stage QA on every submission for this reason.

3. Data security and confidentiality

Regulatory dossiers are among the most sensitive documents a company owns. Require an NDA before any file moves, encrypted transfer, role-based access limited to the named project team, an audit trail, and a clear retention-and-purge policy after delivery.

4. Turnaround and capacity

Volume and deadlines are where vendors are really tested. Ask for realistic turnaround commitments and evidence of capacity under pressure. As a benchmark, B2K sustains roughly 60,000 pages per month across 24×6 three-shift coverage, and has delivered 1,626 pages across 394 files in 3.5 days for a super-urgent Language Solutions project.

5. Continuity and ownership

Publishing quality depends on people who know your product. Favour a partner that keeps the same team on your account, avoids uncoordinated subcontracting, and gives you one point of accountability.

Questions to ask on the call

• Which regions and formats do you support today, and how are you preparing for eCTD 4.0?
• Walk me through your QA steps for a single sequence.
• What happens to my files after delivery, and what is your retention policy?
• What turnaround can you commit to for a dossier of this size, and what is your surge capacity?
• Will the same team stay on my account, and who is my single point of contact?

Red flags

• Vague or one-line answers about QA and validation.
• No NDA, or reluctance to describe data handling.
• Turnaround promises with no capacity evidence behind them.
• Work quietly split across uncoordinated subcontractors.

Run a pilot

The best due diligence is a small paid pilot on a real (or realistic) sequence. It reveals communication, QA discipline and how the vendor handles the messy edge cases that never appear in a sales deck.

“Ask a vendor to walk you through the QA on one sequence, step by step. How specifically they answer that single question tells you more than any capability deck.”Prashanth Krishna, Practice Head — Content Transformation & Regulatory Operations, B2K