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AI co-pilot for all your regulatory and clinical documentation in life sciences

Generate compliant first drafts of CSRs, PSURs, CMCs  — directly inside Microsoft Word.

AI powered writing
AI for lab records

Regulatory documentation is still slow, manual, and repetitive

Purpose built domain models and tooling, tailor made for life sciences

How Asthra works
Asthra
  • Writers start from blank templates or prior submissions

  • Lots of grunt work – copy-paste, rewriting, summarising, interpretation

  • Quality checks and traceability consume disproportionate time

  • Timelines compress, but documentation effort keeps increasing

Asthra work flow

Asthra accelerates drafting without breaking compliance

Asthra helps life sciences teams generate structured first drafts from source content with provenance as defined by writers, with on-demand citations and human-in-the-loop review, so writers can focus on judgement rather than grunt work.

Asthra at a glance

Asthra's AI stack is a perfect mix of speed, quality, cost along with the highest privacy standards in the AI authoring space in life sciences.

Life science documentation

1

Gene Therapy

12 ONGOING RESEARCH PROJECTS

Use this space to promote the business, its products or its services. Help people become familiar with the business and its offerings, creating a sense of connection and trust. Focus on what makes the business unique and how users can benefit from choosing it.

2

Oncology

5 ONGOING RESEARCH PROJECTS

Use this space to promote the business, its products or its services. Help people become familiar with the business and its offerings, creating a sense of connection and trust. Focus on what makes the business unique and how users can benefit from choosing it.

3

Drug Discovery & Delivery

8 ONGOING RESEARCH PROJECTS

Use this space to promote the business, its products or its services. Help people become familiar with the business and its offerings, creating a sense of connection and trust. Focus on what makes the business unique and how users can benefit from choosing it.

3

Drug Discovery & Delivery

8 ONGOING RESEARCH PROJECTS

Use this space to promote the business, its products or its services. Help people become familiar with the business and its offerings, creating a sense of connection and trust. Focus on what makes the business unique and how users can benefit from choosing it.

3

Drug Discovery & Delivery

8 ONGOING RESEARCH PROJECTS

Use this space to promote the business, its products or its services. Help people become familiar with the business and its offerings, creating a sense of connection and trust. Focus on what makes the business unique and how users can benefit from choosing it.

Regulatory writing for life science

1

Drafts sections faster

Section-specific AI drafting aligned to client’s own templates

5 ONGOING RESEARCH PROJECTS

2

Stays grounded in evidence

Outputs generated as per provenance specified

8 ONGOING RESEARCH PROJECTS

3

Works inside Word

No new authoring environment for writers

8 ONGOING RESEARCH PROJECTS

4

Supports quality & review

On-demand citations enable easy review and quality assessment

12 ONGOING RESEARCH PROJECTS

1_From Blank pages 2_1.gif

Where teams use Asthra today

Whether you’re discovering drugs or documenting them for others — Asthra makes your writing as smart as your science.

CSR authoring 

Generate 100% initial draft (data-dependent and non-data-dependent sections) from relevant source documents such as protocols.

  • Slash document turnaround time

  • Ensure consistency and compliance across global submission formats

  • Reduce outsourcing dependency and cost overruns
     

Aggregate reports automation

Generate 70-80% of your PSURs, DSURs, PBRERs.

  • Generate high-quality drafts across multiple client formats

  • Improve the output of regulatory writers without compromising quality

  • Offer AI-powered writing as a competitive edge in your services

Others

Contact us for additional requirements.

  • Generate high-quality drafts across multiple client formats

  • Improve the output of regulatory writers without compromising quality

  • Offer AI-powered writing as a competitive edge in your services

Where teams use Asthra today

Whether you’re discovering drugs or documenting them for others — Asthra makes your writing as smart as your science.

CSR authoring 

Generate 100% initial draft (data-dependent and non-data-dependent sections) from relevant source documents such as protocols.

  • Slash document turnaround time

  • Ensure consistency and compliance across global submission formats

  • Reduce outsourcing dependency and cost overruns
     

Aggregate reports automation

Generate 70-80% of your PSURs, DSURs, PBRERs.

  • Generate high-quality drafts across multiple client formats

  • Improve the output of regulatory writers without compromising quality

  • Offer AI-powered writing as a competitive edge in your services

CMC modules

Leverage Asthra’s multi-step consolidation workflows to collate information from 100s of source documents. Generate entire Module 3 in a few hours.

  • Generate high-quality drafts across multiple client formats

  • Improve the output of regulatory writers without compromising quality

  • Offer AI-powered writing as a competitive edge in your services

Others

Contact us for additional requirements.

  • Generate high-quality drafts across multiple client formats

  • Improve the output of regulatory writers without compromising quality

  • Offer AI-powered writing as a competitive edge in your services

BGS in Numbers

75

Employees

$100

In Investments

224

Partners Worldwide

15

Publications

25

Ongoing Research Programs

Press

BGS appoints Andrew Kim as Board Director

AGIAI Science Journal
November 2035

Therapeutics Giant Announces Collaboration With San Francisco’s BGS

Biotech Frontier Review
May 2035

There’s a New Kid in Town, Changing the Face of Genetic Engineering.

IBRM Magazine
March 2035

Designed for regulated environments

01

Uses only the source documents you provide. Closed to the internet and to the LLM’s own knowledge.

02

Flags missing or inconsistent data instead of fabricating (no hallucinations).

03

Supports 2 levels of traceability for review and audit readiness.

04

Validated and compliant with required certifications (SOC2, ISO27001 etc.).

Testimonials

“Pharmacovigilance teams are under increasing pressure to do more with greater speed and consistency. Asthra applies AI in a thoughtful, compliant-aware manner—automating the heavy lifting while keeping expert oversight central. It represents the direction PV documentation and reporting needs to move toward”

Varun Dua

Founder, PV Analytica

Ex-MD, Deloitte

Learn more about AI in regulatory writing

How GenAI is taking CSR timelines from three months to less than 10 days

Manual Clinical Study Report (CSR) authoring is time-consuming, costly, and prone to errors. Any delays in creating a first draft directly impact regulatory submission timelines, which in turn delay time-to-market.

Fully traceable Module 3 first drafts in hours with Asthra

Traditional CMC authoring is often thousands of pages long, built with critical data from development, manufacturing, QC and supply chain systems.As the primary source of evidence for a drug, accurate and traceable drafts are a non-negotiable.

  • Change the text and add your own content, including any information that is relevant to share.

  • This is a paragraph where you can include any information you’d like. It’s an opportunity to tell a story about the company.

  • Describe a feature you’d like to share about this company or highlight a particular service it offers.

See Asthra on your documents

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