Pharma
Pharma Regulatory AI That Hits Every Submission Deadline
Assyro is the pharma regulatory AI that compresses submission cycles from weeks to days. AI-powered drafting, real-time eCTD validation, and traceable execution across every NDA, sNDA, and IND so your team ships faster without adding headcount.
Challenges We Solve
- Cross-functional teams misalign on Module 2 summaries weeks before submission lock
- Manual eCTD assembly creates structural defects caught too late to fix cleanly
- NDA and sNDA rework cycles cost $150-250K and push back PDUFA dates
- Regulatory intelligence is scattered across 5+ tools with no single source of truth
- New hires take 3-6 months to become productive on submission workflows
How Assyro AI Helps
- Cut NDA and sNDA prep time by 60% with AI-assisted drafting and automated readiness checks
- Validate eCTD sequences in real time against FDA technical specs before gateway dispatch
- Align Regulatory, CMC, and Clinical teams in one tracked workspace with full traceability
- Track regulatory guidance changes and deficiency patterns automatically across all active programs
- Onboard new RA staff in days with reusable, pre-configured submission workflows
Regulations We Cover
Solutions by Role
Explore how Assyro AI helps specific teams within pharmaceutical companies.
Regulatory Affairs
RA professionals spend 60% of their time on manual drafting, formatting, and regulatory tracking instead of strategic work. Assyro automates the grind so you focus on the decisions that actually move submissions forward.
Quality/QA
Assyro AI helps quality assurance professionals maintain GxP compliance, track regulatory inspections, and ensure documentation integrity. Stay audit-ready and proactively address quality issues with AI-powered intelligence.
Clinical
Assyro AI supports clinical development professionals with regulatory intelligence for trial design, IND submissions, and global clinical requirements. Navigate the regulatory landscape confidently from Phase 1 to NDA.
CMC
CMC teams rebuild Module 3 documentation 2-3 times per submission cycle because quality gaps surface late. Assyro validates continuously as you build so packages are right the first time and post-approval changes don't create rework cascades.
PV/Drug Safety
Assyro AI supports pharmacovigilance professionals with regulatory intelligence on safety reporting requirements, signal detection, and risk management. Stay compliant with global PV obligations and evolving safety standards.
Frequently Asked Questions
Teams using Assyro draft regulatory documents 14x faster and cut validation time by 50%. On a typical NDA cycle, that translates to 100+ recovered hours and $150-250K in avoided rework, contractor fees, and delayed revenue.
Yes. Assyro supports all major FDA submission types with pre-configured workflows for each. The same execution system handles original applications, supplements, amendments, and annual reports.
Assyro validates your eCTD sequences against FDA gateway technical specs in real time as your team works. Structural, lifecycle, and metadata defects are flagged with specific fix instructions before dispatch.
Most publishing tools validate after the fact. Assyro validates continuously during the drafting and review process, so defects never reach your publishing step. It works alongside your existing stack, not instead of it.
Ready to Transform Regulatory Operations?
See how Assyro AI can accelerate submissions and ensure compliance for your pharma team.
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