Regulatory intelligencefor life sciences.
From first-in-human to first approval. Make critical development decisions with clarity.
Four purpose-built products: IND Readiness for early-stage filings, NDA Readiness for pre-submission filing-gate intelligence, Device Readiness for FDA 510(k) clearance, and Asset Acquisition for BD diligence.
- Pre-IND meetingQ3 2024Closed · minutes archived
- IND submissionQ1 2025In progress · 3 open gaps
- Phase 1 readoutQ4 2025
- NDA filing gateQ2 2027
Built against the regulatory frameworks your reviewers actually cite.
21 CFR aligned
EU regulatory ready
Global harmonization
GLP standards
Four products. Drugs, devices and diligence, end to end.
From first-in-human filings through pre-NDA submission, FDA 510(k) device clearance and BD asset diligence, Alenvo gives life-sciences teams a structured, evidence-driven view of where every program and opportunity stands.
IND Readiness
Assess your IND package completeness with a structured, weighted scoring system across all regulatory domains.
- 28-question assessment framework
- Domain-level weighted scoring
- Risk visualization & recommendations
- Portfolio analytics dashboard
IND Readiness
Program ALV-2847
NDA Readiness
Program ALV-3104 · 505(b)(1)
Filing Gate
Approval Outlook
NDA Readiness
Pre-submission filing-gate and approval-risk intelligence across 15 evaluation domains. Built for late-stage programs preparing for NDA, BLA, or 505(b)(2) submissions.
- 15-domain evaluation framework (Clinical, CMC, Labeling, Module 1, eCTD, more)
- Filing gate: Ready-to-File, At-Risk, or Refuse-to-File signal
- Approval probability with positive and negative drivers
- Cross-module inconsistency and blocker detection
Asset Acquisition
Structured diligence for BD, corporate development, and investment teams evaluating drug assets for acquisition, licensing, or partnership. Convert disparate data rooms into IC-ready recommendations.
- Six-domain asset scorecard (Clinical, Regulatory, IP, Commercial, CMC, Strategic)
- Cross-asset triage matrix to compare opportunities side-by-side
- Diligence risk register with severity, mitigations, and owners
- IC-ready recommendation with confidence band and evidence trail
Asset Acquisition
Project ALV-DD-118 · Oncology in-license
IC Recommendation
Confidence
Device Readiness
Now availableTraditional 510(k) readiness for non-IVD Class II medical devices. See where your package stands, what evidence is missing, and what to fix first before FDA review.
- Eight review domains, from predicate strategy to QMSR
- Submission-critical gaps and evidence coverage side by side
- Remediation queue with owners and due dates
- eSTAR preparation checklist
Device Readiness
Sample device · Traditional 510(k), Class II
Built by regulatory and clinical operations experts.
Purpose-built for life sciences teams who own the highest-stakes FDA milestones.
Trusted by regulatory teams.
See how biotech and pharma companies are using Alenvo to streamline their submissions.
"Alenvo cut our IND preparation time by 40%. The gap analysis feature alone saved us from a major deficiency letter."
Priya
VP, Regulatory Affairs, Mid-stage clinical biotech
"Finally, a tool that speaks our language. The CMC section questions are exactly what FDA reviewers look for."
Daniel
Director, CMC Development, Early-stage cell therapy startup
"The risk visualization helped our leadership team understand where we needed to invest before our pre-IND meeting."
Margaret
Chief Medical Officer, Late-stage oncology biotech
The earlier you can see where the gaps are, the cheaper they are to fix. That is the whole job.
Ready to get started?
Request a trial and see how Alenvo can streamline your regulatory and clinical planning.