Intelligence

Account

BioNex Therapeutics

Mid-sizeBiotechnology

Geography

United States (Princeton, NJ) — offices in London, Singapore

Dr. Priya Mehta

VP Regulatory Affairs

Regulatory Affairs

Former FDA CDER reviewer. 20+ years in regulatory. Led 12 NDA/MAA approvals. Deep biologics expertise.

Senior RA decision-maker with FDA insider background. Will respond to data-driven, peer-level conversations. Avoid overselling.

Executive Briefing: BioNex Submission Dossiers

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5-Minute Script

What to say on a quick intro call

1 min read

Hi Dr. Mehta, I'm Suren Dheen from Freyr Solutions — I noticed your background includes time at FDA CDER before moving into industry, so I'll skip the basics and get straight to what I think matters for BioNex right now.

With your NDA submission coming up later this year and two compounds in Phase 2, you're entering the period where regulatory execution either accelerates or stalls your timeline. Freyr has completed over 5,000 regulatory submissions globally, and our team includes former FDA and EMA reviewers — people who know exactly what the agency expects to see.

Specifically for BioNex, I think two things are worth a conversation: first, our CTD dossier preparation service where we've consistently cut submission prep time by 30-40% for companies your size. Second, our Regulatory Intelligence service — given that you're working across FDA and EMA simultaneously, having automated monitoring across 120+ agencies in one place would remove a lot of manual tracking burden from your team.

I'm not here to sell you a contract today — I'd love 20 minutes with you and whoever owns the NDA prep to show you specifically how we've handled submissions for similar biologics pipelines. Would next week work?

Type to edit·199 words

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Pitch materials created

Matched against the Freyr knowledge base

Jul 16, 2026 • 4:58 PM

In Progress

Had intro call. She is interested in CTD dossier support. Sending proposal next week.

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Executive Briefing: BioNex Submission Dossiers

Engagement

History