PharmaStabilityAI
Experience unmatched accuracy, intelligent automation, and data-driven insights with our latest innovation in pharmaceutical stability testing. PharmaStabilityAI is crafted to empower researchers, optimize workflows, and accelerate every stage of your drug development journey, ensuring reliable work product stability and superior quality control.
Why Choose PharmaStabilityAI
Fast Stability Report Generation
Generate complete stability study and shelf‑life reports in minutes instead of days. Automated calculations and ready‑to‑use templates eliminate manual spreadsheets and reduce human error.
ICH Q1 Compliant Analysis
Analyse stability data using methods aligned with ICH Q1 guidelines. The software structures outputs in a format suitable for FDA, EMA, and WHO submissions to support smooth regulatory review.
AI‑Enhanced Accuracy & Automation
Leverage advanced regression models and intelligent checks to detect trends, out‑of‑trend results, and data issues automatically. Built‑in statistics improve prediction accuracy and decision making.
Easy‑to‑Use Desktop Application
Intuitive screens and guided workflows let non‑statisticians run stability studies and predictions confidently. Install on your own PC, keep data local, and export clear reports with a few clicks.
Use Cases
Shelf‑Life Estimation from Accelerated Data
Estimate long‑term shelf life using short‑term accelerated stability data. The software fits regression models to your time‑point results and extrapolates when potency will reach the predefined acceptance limit.
Batch Quality Control & Release Decision
Evaluate the stability profile of a single batch to confirm that potency and other quality attributes stay within specification over time. Generate a clear stability report that supports QA review and final batch release decisions.
Environmental Factor Impact Adjustment
Study how storage conditions such as temperature, humidity, or light exposure influence degradation for a batch. Adjust your interpretation of results by considering these factors so that true stability behavior is separated from environmental variation.
Regulatory Submission Support
Produce stability tables, graphs, and summaries in a format aligned with ICH Q1 expectations. Use these outputs directly in CMC and stability sections of regulatory dossiers to justify assigned shelf life and storage conditions.
Key Features
Stability Study Regression Modeling
Model stability data for a single batch using linear regression tailored to pharmaceutical studies. Visualize the degradation trend over time and build a solid basis for assigning shelf life to that batch.
Shelf‑Life Prediction with Confidence Intervals
Predict when a single batch will reach the predefined potency limit and display the result with confidence intervals. Give QA and regulatory teams a clear, quantitative shelf‑life estimate for that specific batch.
ANCOVA and Covariate Adjustment
Refine single‑batch stability results by adjusting for covariates such as temperature, humidity, or initial assay value. Use ANCOVA models so external factors are separated from the true degradation behaviour of the batch.
Regulatory‑Ready Report Generation
Export structured stability reports for each batch, including tables, graphs, and model details in ICH Q1‑aligned formats. Use these reports directly in CMC documentation and internal batch release records.
Sachin Gohil
CEO
Sachin Gohil, with his experience in AI, Machine Learning, Generative AI and Odoo development, helps us leverage technology to optimize our processes and deliver innovative solutions. He is committed to driving success and utilizes his technical expertise to elevate the company to the next level