Validated for regulated life sciences
Accelerate science without compromising compliance.
Pharma and biotech teams use Lockdale to draft submissions, monitor trials, and interrogate research data—running entirely inside their AWS, Azure, or GCP environments.
Built around the realities of your operations
Each deployment is tuned to your workflows, systems, and compliance guardrails—so teams adopt it on day one.
Submission authors stay inspection-ready
Draft Module 2 summaries and responses with traceable citations and version history tied to your validation pack.
Real-time trial oversight
Blend EDC, lab, and safety feeds to detect protocol deviations and missed visits before they escalate.
GxP controls out of the box
Electronic signatures, audit trails, and retention policies align with CFR Part 11 and global regulators.
Outcomes pharma & biotech teams see in the first 90 days
Numbers are based on anonymized averages across recent deployments.
35% faster
Module drafting
Writers re-use structured data and templates without leaving validated environments.
24/7
Trial signal monitoring
Automated digests surface safety trends and enrollment gaps instantly.
0 PHI offshore
Data residency breaches
Every dataset stays within approved regions using your own encryption keys.
The roadblocks holding pharma & biotech teams back
Lockdale is designed to sit inside your environment so every bottleneck is addressed without adding compliance risk.
- Regulatory affairs teams spend weeks assembling IND and NDA modules
- Clinical operations rely on manual reviews to spot protocol deviations
- Quality investigations stall while teams gather batch and CAPA records
- Scientists cannot search across historical experiments and SOPs efficiently
- Public AI tools are blocked due to HIPAA, GDPR, and trade-secret exposure risk
How pharma & biotech teams use Lockdale day-to-day
We tailor automations and copilots to your documents, terminology, and approval flows so adoption sticks.
Regulatory Submission Assembly
Auto-draft CTD sections with cited trial data, tables, and region-specific formatting that regulatory leads can finalize.
Clinical Trial Oversight
Combine EDC, lab, and safety data to highlight protocol deviations, enrollment gaps, and signal detection opportunities.
Quality Event Investigation
Aggregate deviation reports, batch histories, and prior CAPAs to surface root-cause hypotheses and documentation checklists.
Scientific Knowledge Retrieval
Enable secure semantic search across research reports, SOPs, and publications so teams reuse validated knowledge.
What the first month with Lockdale looks like for pharma & biotech teams
A proven rollout motion that respects your security controls and change-management requirements.
Validation & quality alignment
Review SOPs, validation packs, and change-control needs with QA before installation.
Controlled environment install
Deploy inside your regulated cloud with dedicated workspaces for regulatory, clinical, and quality teams.
Inspection-ready handoff
Deliver updated SOPs, validation evidence, and training to satisfy auditors and health authorities.
Designed to pass security reviews on the first try
Lockdale supports GxP validation, CFR Part 11 controls, and customer-managed retention policies to satisfy regulators during audits and inspections.
Client Result
“Our regulatory writers cut Module 2 drafting time by 35% while improving consistency across regions. Inspectors praised the audit trail during our last pre-approval inspection.”
Priya Iyer, VP Regulatory Affairs
A late-stage biotech synchronized clinical, quality, and regulatory teams through Lockdale ahead of a pivotal filing.
Plan your GxP deployment
Book a demo to review validation packs, SOP updates, and the controls life sciences auditors expect.
We’ll tailor the session to your workloads, compliance needs, and success metrics.