Swarm AI
For pharmaceutical regulatory teams

Your dossiers shouldn't be the reason your molecule waits.

Swarm AI is regulatory automation software for pharmaceutical companies. It catches document issues early, drafts submissions for every market, and keeps every deadline on track — so your team files faster, in more countries.

Book a demo See how it works
Preflight · incoming review Live
COA_Metformin-HCl-500mg_B2410.pdf
Received from QC · checked against ICH Q6A, USP Metformin HCl Tablets monograph, SOP-QA-014
FLAG Dissolution limit differs from the specification filed in Module 3.2.P.5.1
FLAG Residual solvent method reference not listed in the approved method register
PASS Assay, impurities and identity consistent with guideline and filed dossier
Assigned to QC owner · due before dossier lock Caught at intake, not at query
The problem

In pharma, speed to approval is the business. Regulatory is where the days go.

If you run a regulatory team, you will recognise most of this.

01

Problems surface at the very end

A spec mismatch in a COA or a gap in a validation report is found during compilation — or worse, in a deficiency letter. Every late catch means rework, re-signatures and lost months.

02

Same product, rewritten for every country

The data doesn't change between the US, EU, ASEAN or a ROW market — but the format and requirements do. Your team rebuilds CTD, eCTD and ACTD sections by hand, one market at a time.

03

Hundreds of moving parts, tracked in spreadsheets

Submissions, renewals, variations, queries and commitments across markets — living in Excel, email threads and someone's memory. A missed deficiency deadline can cost an approval.

04

Literature searches eat whole days

Finding the right BA/BE studies means building search strategies, tuning keywords and reading hundreds of abstracts across PubMed and other databases.

05

Know-how lives in a few people

Every senior reviewer has their own way of working. New joiners take months to reach the same output, and when someone leaves, their knowledge leaves too.

06

Leadership can't see what's stuck

"Where are we on that filing?" takes three calls to answer. Without a live view of the pipeline, launch planning and business decisions run on guesswork.

Pharma regulatory automation

Four AI products, one for each place your timeline slips.

01 / Review

Preflight

Every document reviewed the moment it arrives — not when it's too late to fix.

A swarm of AI reviewers reads every document that enters your regulatory ecosystem — COAs, validation reports, stability data, DMFs, labels — and checks it against regulatory guidelines, your filed dossiers and your own SOPs.

  • Problems flagged at intake and routed to the document owner
  • Fewer costly reworks and avoidable deficiency letters
  • Documents stay compliant without your team policing every page
When is the problem found?
Today
Received
Compiled
Submitted
Agency query
Found by the regulator. Rework, re-signatures, months lost.
With Preflight
Received
Compiled
Submitted
Approved
Found on day one. Fixed by the owner before it ever reaches the dossier.
02 / Author

Composer

One click. A complete, country-ready dossier section.

Composer turns the data you already have into submission-ready sections that follow each country's guidelines and requirements — without anyone re-keying or reformatting the source data.

  • Full CTD, eCTD and ACTD sections in a single step
  • Country-specific rules applied automatically
  • Do the studies once, file in many countries in parallel
Your data once. Every market's format.
Your source data
Specifications Stability data Process validation BE study report
1 click
USFDA · eCTDModule 3.2.P
EU · eCTDModule 3.2.P
ASEAN · ACTDPart II · Quality
WHO PQ · CTDModule 3 · Quality Ready
No re-keying. No reformatting. The data never changes — only the format does.
03 / Track · RIMS

Control Tower

Every submission, query and deadline — in one view, with nothing slipping through.

A regulatory information management system built for how your team actually works. Design your own workflows, set reminders, and let AI keep the moving parts moving.

  • Detects deficiencies raised by regulators automatically
  • Finds the right person in your team and assigns it
  • Follows up until the response is in, so deadlines are met
  • Live visibility for the team and management, across markets
A deficiency letter, handled Response due in 10 days
Metformin HCl Tablets 500 mg · USFDA Information Request on the dissolution method
  1. DETECTEDInformation Request picked up from the ANDA correspondence
  2. ASSIGNEDRouted to the Formulation Development lead — owner of Module 3.2.P.2
  3. FOLLOWING UPReminder sent · draft response in review
  4. ON TRACKResponse submitted before the deadline
Nobody had to notice it, forward it or chase it.
04 / Research

Scout

Ask for the paper you need. Get it in minutes, not days.

Scout searches across PubMed and millions of records in other scientific databases. No search plans, no keyword tuning — describe what you're looking for in plain language.

  • Reads the abstracts for you and ranks what's relevant
  • Finds supporting BA/BE studies for your dossier quickly
  • Every result linked back to its source for your review
Just ask
Bioequivalence studies of metformin 500 mg immediate-release tablets in healthy volunteers
PubMed + other databases searched Abstracts read and ranked
Bioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon® & Glucophage®) in healthy human volunteersStrong match
Biopharm Drug Dispos · 2002 · 24 volunteers · fasting · two-way crossover
Pharmacokinetics and bioequivalence of two brands of metformin 500 mg tablets in Iranian healthy volunteersStrong match
J Pharm Investig · 2014 · fasting · single-dose, two-period crossover
Fed bioequivalence study of 2 metformin 500 mg prolonged-release tablets in 28 healthy volunteersPartial match
ClinicalTrials.gov NCT05124717 · ranked lower: prolonged-release, not immediate-release
05 / The platform

Swarm AI Workspace: all of regulatory, in one place.

Preflight, Composer, Control Tower and Scout come together as one collaborative platform. Your team reviews, writes, tracks and researches without ever leaving the system — and every decision, comment and version stays in one place.

REVIEW Preflight
AUTHOR Composer
TRACK Control Tower
RESEARCH Scout
Shared workspace Documents · workflows · comments · audit trail
Security & privacy

Your dossier data stays yours. You choose where it lives.

We value your privacy. Your formulations, specifications and study data are your most valuable IP, so every customer gets an environment that is theirs alone.

Option A

Private deployment

Swarm AI runs inside your own infrastructure. All of your company's data stays on your servers, behind your firewall and under your IT policies.

Best for companies with strict data-residency or in-house IT requirements.
Option B

Swarm Managed

A completely separate, isolated account set up only for your company and managed by Swarm AI. Your data sits in its own environment, never shared with other customers, and you never have to run the infrastructure.

Best for teams that want full isolation without managing servers.

AWS security best practices

Every environment is built and run following AWS security best practices.

No third-party exposure

We don't use any third-party dependency that has access to your data.

Your data, your control

Isolated per company, with a full audit trail of every action, comment and version.

What changes for your business

Same team. Many times the output.

Multiply output, not headcount

Review, authoring and research that took days take minutes. Your existing team produces several times more submissions.

File in many countries at once

Run your studies once and apply for approvals in multiple markets in parallel — without a new rewrite for each one.

A process, not silos

Your best reviewers' standards are built into the system. A new joiner delivers the same quality of output in weeks, not months.

Full visibility for leadership

Management and partner teams see live status, bottlenecks and success rates — so launch and portfolio decisions are made on facts.

Built for every seat in regulatory.

Leadership & management

"Which approvals land this quarter, and what's blocking the rest?"

Answered in one dashboard, any time.

Head of Regulatory Affairs

"How do I take on more markets without hiring a team per region?"

Parallel filings, one consistent process.

Regulatory associates

"I want to spend my time on science, not on formatting and chasing."

The repetitive work, handled.

Questions

Pharma regulatory automation, answered.

What is pharma regulatory automation software?

It is software that takes repetitive regulatory affairs work off your team: reviewing documents against guidelines and SOPs, drafting CTD, eCTD and ACTD dossier sections, tracking submissions and agency queries, and searching scientific literature. Swarm AI does all four in one AI-powered platform built for pharmaceutical companies.

Which submission formats and markets does Swarm AI support?

Swarm AI generates dossier sections in CTD, eCTD and ACTD formats and applies country-specific requirements, for markets including the USFDA, EU, ASEAN and WHO Prequalification. Your source data is entered once and reused for every market.

How does AI document review reduce deficiency letters?

Preflight checks every document the moment it reaches your regulatory team — COAs, specifications, validation and stability reports — against ICH guidelines, pharmacopoeial monographs, your filed dossiers and your SOPs. Gaps are flagged and routed to the document owner at intake, instead of surfacing later as an agency query.

Is Swarm AI a regulatory information management system (RIMS)?

Yes. Control Tower is Swarm AI's RIMS. It tracks submissions, renewals and agency correspondence, detects deficiencies raised by regulators, assigns them to the right person and follows up until the response is filed — with live visibility for management.

Can Swarm AI find BA/BE studies and literature for a dossier?

Yes. Scout searches PubMed and other scientific databases from a plain-language question, reads the abstracts and ranks the most relevant bioavailability and bioequivalence studies, with every result linked to its source.

Where is our regulatory data stored?

You choose. Swarm AI can run as a private deployment on your own servers, or in a dedicated, isolated account managed by Swarm AI. We follow AWS security best practices and use no third-party dependency with access to your data.

The founders

Talk directly to the people building it.

Swarm AI is founded by two IIT Roorkee engineers who have built data and software systems at Amazon and Unilever — and who have spent over a year working inside pharma regulatory, alongside the teams we build for. Write to us — you'll hear back from a founder.

Sarthak Jain

Sarthak Jain

CEO · Director

Ex-Software Engineer, Amazon · IIT Roorkee

sarthak@swarmaisciences.com
Manan Jain

Manan Jain

CTO · Director

Ex-Data Science Manager, Unilever · IIT Roorkee

manan@swarmaisciences.com

See your next filing move faster.

Bring one real document. We'll run it through Preflight live and show you what it catches.

Book a demo Talk to the founders