AI assisted workflows for pharmaceutical processes
Structured, template-driven workflows where AI handles complex tasks and humans make final decisions.
Structured, template-driven workflows where AI handles complex tasks and humans make final decisions.
Deploy proven workflow patterns in days. Create custom templates that match your processes—no months of customization required.
From fully automated to human-reviewed, you control the level of AI autonomy. Configure each step for the right balance of speed and oversight.
Every action logged for regulatory compliance. Immutable change tracking, version control, and approval workflows designed for 21 CFR Part 11.
Create custom workflows for your processes. Define step types, role assignments, validation rules, and AI instructions—all without code.
Transform complex regulatory documents into structured, traceable knowledge. AI interprets source materials against authoritative schemas, synthesizes findings with full citation chains, and delivers outputs your reviewers can trust.
Collect complete, validated information the first time. AI guides users through constraint-aware intake—asking clarifying questions, flagging inconsistencies, and ensuring submissions meet requirements before they reach your team.
Build confidence before submission. Multi-role review cycles with audit trails ensure nothing reaches regulators or stakeholders without proper oversight. Governance built into every workflow, not bolted on after.
A workflow-native AI system that helps teams create or assemble regulatory and scientific outputs using structured steps, role handoffs, and your existing documents.
Regulatory, legal, and scientific document schemas
Query FDA labels, clinical trials, and biomedical literature directly within any workflow step—no switching between systems or databases
Every workflow follows a clear pattern: gather inputs, process and validate, then deliver structured outputs. Configure each step for full automation or human review.
AI: Accepts partial input, guides clarification
AI: Validates rigorously, flags issues
AI: Ensures formatting and accuracy
Mix step types across phases. Configure automation and human involvement per step.
Most teams are stuck in pilots because generic AI tools require months of customization. Cogniphai ships workflow-ready AI that uses authoritative pharma data to guide teams through structured execution and document assembly—deploy in days, not months.
Industry insight: McKinsey reports that only 32% of life-sciences orgs have started to scale gen-AI (Jan 2025).
Cogniphai unifies trials, labels, targets, chemistry, and safety into one searchable layer with lineage and normalization.
Industry insight: Deloitte identifies data silos and non-FAIR data as key industry challenges.
Built-in policy controls, auditability, and key management align with emerging AI regs and SOP needs.
Industry insight: Deloitte notes governance lags behind AI adoption · EY survey highlights regulatory concerns.
Cogniphai detects, dedupes, and routes PV and regulatory signals from FAERS, literature, and labels with traceable citations.
Industry insight: IQVIA discusses safety and compliance challenges in pharmacovigilance (Sep 2025).
Configure workflows with optional human review steps to catch AI errors. Validation gates ensure quality before handoff, with citation tracking for every AI-generated claim.
Industry insight: Nature Biotechnology highlights the importance of human oversight in biomedical AI applications.
We start with a clearly scoped 90-day pilot focused on one or two real production workflows. Cogniphai is configured to your documents, templates, roles, and review requirements, with AI operating inside defined steps and human approval gates.
Each pilot has explicit success measures agreed up front, such as cycle-time reduction, reduced manual handling, improved completeness, and reviewer confidence. Outcomes are observable, auditable, and tied to real operational work.
Successful pilots transition into an ongoing subscription. Additional workflows are added incrementally, and automation can increase over time where teams are comfortable. Cogniphai becomes part of standard operating processes, not a one-off experiment.
