“Your CMC package reviewed for quality and compliance.”

CMCReview AI processes your Chemistry, Manufacturing and Controls documentation — formulation data, manufacturing process descriptions, stability study reports, analytical method validations, and bioequivalence study results — and reviews each element against FDA 21 CFR Part 314, ICH Q-series guidelines, and EMA CMC requirements. Your CMC team receives a structured gap report identifying every deficiency with the specific regulatory citation before the submission reaches the health authority.

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Agent Details

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IndustryPharma · Life Sciences

Output typeCMC compliance gap report

Data isolation✓ 6 layers

Audit trail✓ Immutable

This agent produces finished work ready for your team’s review and approval. It completes entire workflows — not just suggestions or partial answers.

Features

What CMCReview AI does.

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Formulation and manufacturing process review

Reviews your drug product formulation, manufacturing process narrative, in-process controls, and batch records against FDA and EMA expectations — flagging gaps in process validation documentation, missing control parameters, and inadequate out-of-specification handling procedures.

📊

Stability data validation against ICH Q1A

Verifies that your stability study design, storage condition testing, and data points support your proposed shelf-life claim under ICH Q1A(R2) requirements — identifying missing accelerated or long-term data points, statistical analysis gaps, and unsupported expiry date claims.

🔬

Bioequivalence data consistency review

Reviews your pharmacokinetic and bioequivalence study reports for statistical consistency — checking that Cmax and AUC 90% confidence intervals fall within the 80 to 125 percent FDA acceptance range and that the study design meets current FDA BE guidance.

⚠️

Impurity control strategy assessment

Checks your impurity control strategy for degradation products, process impurities, and elemental impurities against ICH Q3A, Q3B, and Q3D thresholds — verifying identification and qualification thresholds are met and appropriate supporting studies are documented.

Advantages

Why it matters to your team.

The real operational benefits your team will experience — described in terms of the work you will no longer have to do, and the outcomes you will achieve instead.

CMC deficiency letters resolved before they are issued

CMC-related deficiency letters are among the leading causes of ANDA review delays — often adding six to twelve months to approval timelines. CMCReview AI identifies the same gaps before submission, turning post-filing deficiencies into pre-filing fixes.

Specialist CMC expertise applied consistently at scale

CMC review requires coordinated expertise across formulation science, analytical chemistry, and regulatory science. CMCReview AI applies the same consistent specialist-level scrutiny to every submission regardless of team capacity or workload pressure.

Structured gap report replaces free-form document review

Your CMC scientists receive a structured report identifying specific deficiencies with regulatory citations — replacing hours of free-form document review with a targeted remediation workflow that directs effort exactly where it is needed.

Simultaneous multi-authority compliance checking

CMCReview AI checks your CMC package simultaneously against FDA, EMA, and CDSCO requirements — identifying authority-specific gaps that would otherwise only be discovered when each submission reaches that authority months into the review process.