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About Asthra

We're building the writing layer for regulated science.

Asthra was founded by a team that has lived inside the regulatory writing process — and a team that has built large-scale AI systems. We bring those two worlds together so writers get leverage without losing trust.

Regulatory writing is one of the most consequential text-creation jobs in the world. A CSR can decide whether a drug reaches patients. A PSUR can flag a safety signal years before it would surface otherwise. The text matters — and the provenance of the text matters even more.

Generic AI doesn't fit this work. Hallucinations are a non-starter. Open-internet retrieval pollutes the source set. “Rewrite this paragraph” is not the unit of work that ships.

So we built Asthra around the actual unit of work: a section, drafted from a writer-approved source set, cited at the sentence level, reviewed by a human, and shipped with an audit ledger. Speed without compromising compliance.

Principles

How we build.

PRINCIPLE / 01

Writers stay in charge

The agent proposes; the writer disposes. Every retrieval plan, every source decision, every section is reviewable before anything ships. Asthra never overrides judgment.

PRINCIPLE / 02

Closed beats clever

We chose closed-system retrieval over the open internet, deterministic citations over plausible-sounding synthesis, and explicit gap flags over confident guessing. Less magic, more trust.

PRINCIPLE / 03

The ledger stays with the document

Audit readiness can't depend on a vendor staying in business. Every claim, every retrieval, every edit is captured in an append-only ledger embedded in the .docx itself.

Team

Who's behind Asthra.

A founding team of regulatory operators and AI engineers, backed by senior advisors in pharma safety, CMC regulatory affairs, and US R&D strategy.

Founders
GP
Dr. Padmanabhan Guruprasad
Founder & CEO
Ex-Novartis Associate Director with 17+ years in pharmaceutical operations and regulatory processes. AIIMS MD/DM in drug development; IIM Calcutta alumnus. Founded Asthra after observing that the biggest bottleneck in regulatory writing was not scientific complexity but mechanical effort.
LinkedIn ↗
VR
Vishnu Ramesh
Founder & CTO
BITS Pilani alumnus and AI engineer. 5+ years building private RAG and document-intelligence systems for regulated environments — including SBI, defense, and Parexel deployments. Built Asthra's core technology stack in partnership with IIIT-Hyderabad.
LinkedIn ↗

Talk to the founders.

Guru and Vishnu run pilot scoping calls themselves. 30 minutes, your real document type, no slide deck.

Book a call with the founders →
Senior advisors
IW
Ingrid Witherell
Writing Partner · Safety / Medical Writing
25+ years in safety surveillance and aggregate safety reporting. 100+ high-stakes filings across INDs, DSURs, and NDAs. Heads up Asthra's done-for-you writing services and shapes the safety-document rule sets. Co-hosts joint Asthra walkthroughs and webinars; partners with sponsor teams on PSUR and IB drafts.
LinkedIn ↗
VC
Vidhyasree Chandu
SME · Global Regulatory Affairs (CMC)
21+ years in end-to-end CMC regulatory affairs across the US, EU, China, LATAM, and ASEAN. Lifecycle strategy expert. Advises Asthra on CMC-heavy regulatory workflows and the realities of running global filings at scale.
LinkedIn ↗
AS
Dr. Ajay Srivastava
Strategic US R&D Advisor · DVM, MS, PhD
25+ years of US R&D and scientific leadership spanning 500+ pharmaceutical and nutraceutical products. Expertise in external innovation, global CRO alliances, and IP strategy with 12+ patents issued or pending.
LinkedIn ↗
Our stack

Built on platforms that take regulated writing seriously.

AnthropicClaude API
MicrosoftWord add-in
PV AnalyticaSafety advisory
+ pilot partnersPharma · device

Talk to the team.

We're early, focused, and selective about pilots. If your team writes regulated documents, we'd like to hear about your process.