Bioanalytical validation, reimagined

From instrument data
to FDA-ready in minutes.

Arova parses your workbench files, compares them against an encoded library of FDA and ICH guidance, and surfaces every compliance gap before you submit.

Request a Demo See how it works
Upload your workbench file
MSD, SoftMax Pro, Excel — parsed automatically.
Know every gap before FDA does
Each finding cites the exact guidance section it maps to.
Submission-ready audit trail
A traceable record of every check, ready to file.
Encoded guidance documents
FDA · 2019
Immunogenicity Testing of Therapeutic Protein Products
ICH · 2022
ICH M10 — Bioanalytical Method Validation
FDA · 2025
Biomarker Validation — Context of Use Framework
AAPS WRIB
Workshop on Recent Issues in Bioanalysis
ICH
ICH Q6B — Specifications for Biological Products
FDA
21 CFR Part 11 — Electronic Records & Signatures
The platform

A single pipeline
from upload to audit trail.

Four precise steps. No manual cross-referencing. No late-stage surprises.

STEP 01

Upload

Drop in your workbench file. Arova detects the instrument and extracts the parameters.

STEP 02

Parse

Results, sample conventions, and metadata are structured into a clean, comparable dataset.

STEP 03

Compare

Your data is checked against our knowledge base of FDA and ICH guidance documents.

STEP 04

Report

FDA-ready compliance report with AI-generated scientific summary — fully auditable.

Instrument-native parsing
Workbench files are ingested as-is — no templating, no pre-processing.
Guidance-linked findings
Every gap cites the exact FDA or ICH section it relates to.
Phase-aware checks
Rules adapt to your submission phase — IND, BLA, or MAA.
Severity-classified gaps
Critical, major, and minor — so your team knows what to triage first.
FDA-ready audit trail
A complete, traceable record shareable with the user for filing.
Living knowledge base
Rules are refreshed as guidance evolves — no code changes needed.
Built for the teams who file

Designed around the people
who validate and submit.

Bioanalytical Scientist
Validate methods with confidence.

Own the bench work, and know which boxes a submission still has open — without cross-checking guidance by hand on a Friday afternoon.

Instant feedback on workbench uploads.
Findings tied to specific guidance clauses.
A clean hand-off to regulatory.
Regulatory Affairs Lead
Walk into FDA calls prepared.

Own the filing — and the risk of CRLs. Get an auditable trail that shows exactly how the submission was checked and what was addressed.

A traceable record of every compliance check.
Critical gaps surfaced before the reviewer does.
Audit trail ready to include in the filing.

Find the gaps
before FDA does.

Request a pilot. Upload your next validation run. See your compliance gaps the same day.

Request a Demo Learn more