Compliance & Validation — Documented
SOC 2 Type II, HIPAA, GDPR
Writer
Enterprise generative AI platform purpose-built for regulated industries including pharma and life sciences.
Writer is a full-stack generative AI platform that lets pharma and biotech companies deploy LLMs trained on their own data, with built-in compliance guardrails. Used for medical writing automation, regulatory document drafting, SOPs, and internal knowledge management. SOC 2 Type II certified with audit trail support for 21 CFR Part 11 environments.
- Headquarters
- San Francisco, United States
- Founded
- 2020
- Compliance
- SOC 2 Type II, HIPAA, GDPR
- Deployment options
- cloud, private-cloud
- Website
- https://writer.com
- https://www.linkedin.com/company/getwriter
Categories
AI Use Cases
- Regulatory Submission Authoring
Vendor Scorecard
100% — Complete coverage. Coverage score — how completely Atlas documents Writer across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud, private cloud
Pricing Transparency — Documented
SaaS subscription
Implementation & Onboarding — Documented
1–3 months
Organization & Role Fit — Documented
Mid-Size Biotech, Large Pharma, Top 20 Pharma, CRO / CDMO, Regulatory Affairs, Medical Affairs, IT / Digital, Data Management
Solution Scope — Documented
Clinical Data Management, Natural Language Processing, Regulatory Submission Authoring
Company Viability — Documented
Series C, $200M raised, 350+ employees, Founded 2020
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Evidence & Outcomes
Achieved the ISO 27001, ISO 27701, and ISO 42001 'trust triad' (security, privacy, AI management)
Writer announced it had achieved an ISO trust triad — ISO/IEC 27001 for information security, ISO/IEC 27701 for privacy information management, and ISO/IEC 42001 for AI management systems — spanning its in-house enterprise AI models and platform.
press release (Writer) · 2025-05-28
Questions to Ask This Vendor
- Do you support 21 CFR Part 11 audit trails for regulated document workflows?
- Can models be fine-tuned on our proprietary medical writing templates?
- What data retention and residency options are available for EU operations?