The filer-side mirror of FDA's structured review

Check your ANDA against the rules the reviewer will apply — before you file.

Your team spent eighteen months developing a generic product. The dossier is compiled, the submission validated. You file — and wait. Doscierge gives you the review lens first.

972Encoded Rules
29Compliance Domains
EveryFinding Evidence-Traced
The problem you already know

Filing is the easy part. The review cycle is where the years go.

⚠
The setup

Eight months of silence, then a Complete Response Letter

The CRL cites a missing intermediate stability condition your team assumed was optional — and a drug-substance impurity that needed identification at your product's daily dose. Another cycle. Another year before launch.

⏳
The tension

This is the norm, not the exception

Fewer than one in four ANDAs is approved on the first cycle. The rest work through multiple review cycles — and each additional cycle pushes launch, and the first-to-file window, further out. The fee is rarely the problem. The lost time is.

✓
The resolution

What if you saw the deficiency first?

FDA reviews your submission against a structured, rules-based assessment. Filers have never had that lens. Doscierge is the filer-side mirror — it checks your draft against the same governing PSGs, CFR, USP, and ICH requirements, and returns evidence-traced findings you can act on before you submit.

The public record

The numbers behind the churn

Drawn from FDA Office of Generic Drugs program statistics and GDUFA III performance reporting.

<1 in 4ANDAs approved on the first cycleFDA OGD, FY2026
~71%of original ANDAs drew a Complete Response LetterGDUFA performance reporting, FY2023
70%+of major first-cycle deficiencies are quality / CMC-relatedFDA Generic Drug Forum
~294 daysmean approval time under GDUFA III — a cycle you don't want to repeatGDUFA III, FY2024 cohort
One tool, three rooms it has to win

Built for the evaluation you'll actually run

Regulatory Affairs
🎯

Catch the deficiency before the reviewer does

Every finding cites the governing PSG, CFR, USP, or ICH clause, with the evidence text and a remediation — the commodity checks and the experience-based ones.

→ First-cycle readiness, deficiency avoidance
Quality & Compliance
⚖

Deterministic. Reproducible. Audit-ready.

Same input, same output, every time. A validation-ready package, ALCOA+ data integrity, and human disposition on every finding — never a black box.

→ GAMP 5-aligned, Part 11-enabling
IT & Digital
🔗

Complements your RIM. No rip-and-replace.

Reads your real PDF, Word, and eCTD dossiers where they live. Doscierge is the content-compliance layer on top of the document system you already own.

→ Clean deployment and security story
🛡
Built to withstand regulatory scrutiny

Every finding traces to its governing PSG, CFR, ICH, or USP clause. Deterministic, reproducible, and architecturally ready for independent SME validation.

🏭
Built by pharma, for pharma

Created by a sixteen-year pharmaceutical industry veteran spanning clinical development, commercial, and manufacturing.

📊
Grounded in the filing record

Informed by analysis of thousands of ANDA submissions and the public deficiency record they leave behind.

Supporting American pharmaceutical independence

Faster filing is faster access — and a stronger domestic supply chain.

Roughly one in ten active pharmaceutical ingredients used in US medicines is made domestically, and most API manufacturing facilities sit overseas. Federal programs — the FDA's ANDA Prioritization Pilot for domestically manufactured generics and its PreCheck Pilot for new domestic facilities — now favor manufacturers who file at home, and reward getting the filing right the first time. Doscierge is the compliance layer that makes first-cycle-ready, domestically sourced filings faster to prepare.

See what Doscierge finds in your filing.

Bring a draft ANDA. We'll show you the evidence-traced findings before it ever reaches a reviewer.

How it works

Upload. Check. Review.

Point Doscierge at a draft ANDA. It checks the content against an encoded requirement corpus and returns findings, each one traced to its regulatory source and ready for your disposition.

1
📤

Upload

Your draft ANDA — PDF, Word, or eCTD package. Processed in isolation; never retained or used for training.

→
2
🔍

Check

The content is checked against 972 encoded rules spanning 29 compliance domains — form-aware, so the right paradigm applies to the right product.

→
3
✅

Review

Every finding shows the governing clause, the evidence text, and a recommended remediation. You disposition each one.

doscierge.orchestraprime.ai/upload

Upload your ANDA draft

📤

Drag & drop your ANDA draft here

Browse files

PDF, eCTD · encrypted at rest · never used for training

…/checking

Checking 29 domains

Each section evaluated against the encoded requirement corpus.

● Stability · ● Bioequivalence · ● CMC
17 of 29 domains complete
…/reviews/mtf-er-500
Major
Intermediate stability condition not specified
ICH Q1A(R2) §2.2.7
Minor
Dissolution profile missing fed-state arm
FDA PSG — Metformin HCl ER
Minor
Container-closure integrity test not referenced
USP <1207>
Under the hood

Deterministic by design, advisory where it helps

The architecture is built to be validatable — and to keep the tool out of the black-box trap.

A deterministic rule engine is the compliance authority

The rules decide compliance — reproducibly, the same way every run. This is what makes the tool validatable and defensible.

Knowledge-graph-grounded advisory for context

A structured regulatory knowledge base surfaces beyond-rule considerations through multi-step reasoning. It advises; it never overrides a rule finding.

Human-in-the-loop — advises, never decides

No automated submission, no automated pass or fail. Every finding requires human disposition. The tool recommends; the regulatory professional decides.

Every finding traces to source

Each finding points back to the governing PSG, CFR, USP, ICH, or RTR clause — with the evidence text that triggered it. No opaque scores.

Evidence trace

Every finding shows its work

A single check, from the text in your dossier to the clause that governs it.

Drug-substance impurity check

Dose-dependent identification threshold

1
Input
What the filing says
3.2.S.3.2 — Impurities
Specified impurity A: 0.12%
Unidentified impurity: 0.14%
Maximum daily dose: 2,000 mg
2
Rule
What Doscierge checks

Identification thresholds scale with maximum daily dose. For a product dosed at or below 2 g/day, any impurity at or above 0.10% must be structurally identified. The reported level is cross-referenced against the dose-dependent threshold.

3
Finding
What Doscierge flags
CriticalUnidentified impurity exceeds the identification threshold
0.14% exceeds the 0.10% threshold for a product with maximum daily dose ≤2 g/day. Must be structurally characterized or otherwise justified.
4
Citation
Why FDA requires it
ICH Q3A(R2), Attachment 1 — identification threshold at 0.10% for maximum daily dose ≤2 g/day.
21 CFR 314.94(a)(9) — the ANDA must fully characterize drug-substance impurities.

Every finding reviewed by your team — Doscierge flags, humans decide.

Coverage

What Doscierge checks

Breadth across the filing, with form-specific depth where it matters.

Filing completeness Bioequivalence design Stability protocols CMC adequacy Process validation Labeling Method validation Impurities & E&L Data integrity Facility & site Ophthalmic Nasal spray Inhalation (MDI / DPI) Injectable / sterile Modified release … and more

What Doscierge does not replace

Doscierge checks regulatory documentation compliance — it is not a medical device and does not assess clinical safety or efficacy. It does not replace clinical study conduct, facility pre-approval inspection readiness, API testing, or your regulatory judgment. Findings require human review and disposition before any submission.

Want the architecture walkthrough?

We'll take your Quality and IT teams through determinism, the validation package, and the integration model.

Why Doscierge

The ANDA filing-quality problem, in the open.

The rules are public. The deficiency record is public. What's been missing is a way to check your own submission against them before you file.

The filing-quality crisis

The fee isn't the problem. The lost time is.

Refuse-to-Receive rates have fallen to roughly 3% — and the fee at stake is largely refundable. The real cost sits downstream, in the multi-cycle churn that eats the exclusivity window.

~3%Refuse-to-Receive rate today, down from about 1 in 10 historicallyFDA OGD
~75%of the filing fee is refundable on a Refuse-to-ReceiveGDUFA
3+ cyclesare common before approval — each one a year of lost timeFDA Generic Drug Forum
GDUFA IIIperformance goals run through the FY2026–2027 periodGDUFA III commitment letter
The 80/20 problem

The commodity 80% is table stakes. The 20% converts skeptics.

📋

The commodity 80%

The checks any careful reviewer catches — present sections, obvious formatting, the requirements written plainly on the face of the guidance. Necessary, but not where filings actually fail.

🧠

The experience-based 20%

Intermediate stability conditions. The DMF-versus-ANDA content boundary. Dosage-form-specific dissolution requirements. Weight-of-evidence bioequivalence for complex products. The judgment a seasoned reviewer carries in their head — encoded.

"Doscierge encodes both — but it's the 20% that proves the tool understands the domain."

The whitespace

Nobody else checks whether your content meets the requirement

The market splits four ways — and only one square is automated and content-aware.

Does not check your content
Checks your content
Automated / Software
Adjacent software

eCTD validators, RIM systems, regulatory-intelligence platforms, AI drafting tools — they format, store, inform, or draft, but don't judge whether your content meets the requirement.

★ Doscierge
The empty square

Filer-side, automated, content-level compliance checking — deterministic and evidence-traced.

Manual / Services
Publishing vendors

Produce and format the submission package — they don't evaluate the science.

Regulatory consultants

The one incumbent that truly checks content — but by hand, at consulting rates, and one answer per reviewer.

"They draft. We verify."

Run it on a product you actually file.

We'll demo on your dosage form — with the depth checks that separate a real review from a checklist.

For Regulatory Teams

Raise the floor on every filing — before it reaches FDA.

"You're a VP of Regulatory Affairs at a mid-size generic manufacturer filing fifteen to twenty ANDAs a year. Your senior reviewers are stretched thin. Each filing gets one pass before submission — and you know that isn't enough for the complex products."

What you get

Findings you can act on and defend

🎯

First-cycle readiness

Surface the deficiencies that trigger a Complete Response Letter — and cost you a review cycle — before a reviewer ever sees the filing. Protect the first-to-file window.

📑

Evidence-traced to the clause

Every finding cites the governing PSG section, CFR, USP chapter, or ICH clause, with the evidence text and a remediation. Nothing opaque to defend to FDA or to your leadership.

🔄

Checked against current guidance

Findings are evaluated against in-force guidance — so you're checking against what applies now, not a superseded draft.

⚖

You stay the decision-maker

Human disposition on every finding. Doscierge is a checklist that frees you for the judgment calls — never a replacement for your expertise or FDA consultation.

The depth test

The 20% that proves the tool understands your domain

A pre-submission review earns its keep in the checks that encode judgment beyond the literal text. A few Doscierge is built to catch:

Intermediate stability conditions

When accelerated data shows significant change, the intermediate condition is no longer optional — miss it and you may be facing a multi-year stability restart.

Cross-module consistency

A patent certification or a claim in one module that contradicts another is the kind of inconsistency a serialized manual pass misses — and a reviewer won't.

Dosage-form-specific dissolution

Multi-pH profiles and the requirements that apply to modified-release products — not single-point logic borrowed from immediate-release.

DMF-versus-ANDA boundary awareness

Don't demand Drug Master File content inside the ANDA body. The false positive that instantly reveals a tool has never seen a real submission — suppressed by design.

Demo — 16s explainer

Evidence trace: from document to finding to governing clause

A stability check on a real ANDA section — see how the encoded requirement matches, what the finding says, and where the citation comes from. Every step traced.

Video available on request →

Coming soon

The deficiency caught before FDA saw it

A real finding, a real cycle saved, in a regulatory reviewer's own words. We're documenting the first customer validations now — if you'd like your filing to be the case study, let's talk.

Get in touch →

Give your next filing the review lens first.

Start with one filing. See the depth on a product you care about.

For Quality & Compliance

Deterministic. Validatable. Human-in-the-loop. Auditable.

"A black-box model that answers differently each run is a non-starter under GAMP 5 Category 5. So Doscierge was architected the other way around — deterministic rules as the compliance authority, with a validation package that ships as a deliverable."

Determinism

Same input. Same output. Provable.

Run the same document repeatedly and you get the identical finding set — an engineered guarantee you can reproduce in your own validation, not a marketing claim.

Same ANDA, repeated runs
✓ Run 1 ✓ Run 2 ✓ Run 3 ✓ Run 4 ✓ Run 5
Identical finding set → version-locked, no drift
The GxP package

What ships with the tool

📜

Validation-ready package

Classified GAMP 5 Category 5 (custom application), AI-based static — a locked model, no drift. IQ/OQ/PQ per the V-model, provided as a go-to-market deliverable rather than something you build yourself.

🔑

ALCOA+ data integrity

Every step from ingestion to disposition is Attributable, Legible, Contemporaneous, Original, Accurate — and Complete, Consistent, Enduring, and Available. Immutable audit trail.

⚖

Human-in-the-loop, mandatory

No automated submission, no automated pass or fail. Every finding requires human disposition — aligned to the emerging regulatory consensus that AI output must be reviewed and cleared by an authorized person.

🔐

Part 11-enabling

Audit trails, access control, and e-signature support. Messaged as Part 11-enabling — the regulation binds your organization; no vendor discharges that obligation, and we won't claim to.

Audit trail

An unbroken digital thread

Every finding carries its full lineage — timestamped, attributable, and enduring.

14:02:11 UTC · document fingerprinted
Document ingested — mapped to the relevant eCTD module
14:02:14 UTC
Section parsed & classified — the impurities section located
14:02:16 UTC
Rule matched — dose-dependent threshold, deterministic
14:02:16 UTC
Finding generated — severity classified, evidence text and citation attached
15:41:03 UTC · actor: RA Manager
Human disposition — accepted, e-signed, routed for remediation

Put the validation package in front of your Quality team.

We'll bring the documentation and a quality agreement with explicit audit rights.

Resources & Insights

Reading for people who file for a living.

Data-grounded perspective on ANDA filing quality, the deficiency record, and the policy shifts reshaping how — and where — generics get filed.

Featured insights

The pieces worth your time

📉
Analysis

What OGD's declining RTR rate really means for filing quality

Refuse-to-Receive has fallen to roughly 3% — but that number hides the real story. The cost has moved downstream into multi-cycle churn, and it reframes the pain from "avoid RTR" to "get the first cycle right."

Read more →
🧠
Deep dive

The 20% of ANDA checks that a rule engine usually misses

The intermediate-stability landmine. The DMF-versus-ANDA content boundary. Q1/Q2 sameness for complex generics. The experience-based depth checks that separate a real review from a checklist — and why they're the hardest to encode.

Read more →
🏭
Briefing

Readiness for the ANDA Prioritization Pilot

Federal programs now reward domestic manufacturers who file — and reward getting the filing right the first time. What the reshoring-driven filing-quality angle means for domestic and domestically sourced submissions.

Read more →
More resources

Primers, infographics, and data

Article

What OGD's declining RTR rate really means for filing quality

The reassuring headline hides where the real money leaks out. RTR is down to ~3%, but CRL rates remain stubbornly high — and ~75% of RTR fees are refundable anyway.

Article

The 20% of ANDA checks that a rule engine usually misses

You can verify every section header and still walk straight into the CRL. The experience-based checks — intermediate stability, DMF boundaries, dosage-form dissolution — are where filings actually fail.

First-cycle outcomes

Share of original ANDAs, public FDA program statistics
Need more than one review cycle~76%
Drew a Complete Response Letter (FY2023)~71%
Major deficiencies that are quality / CMC-related70%+
Approved on the first cycle~24%

Where the deficiencies land

Distribution of major first-cycle deficiencies, illustrative from public forum data
Manufacturing~31%
Drug product~27%
Bioequivalence~18%
Drug substance~9%

Want these in your inbox?

New analysis on ANDA filing quality, published ahead of the major industry events.

About & Contact

Built by pharma, for pharma.

Closing the gap between what filers know and what reviewers expect — from the heart of the US pharmaceutical corridor.

🏢

OrchestraPrime

A New Jersey software company building regulatory and compliance decision-intelligence tools for life sciences, based in North Brunswick — in the heart of the US pharmaceutical corridor. Doscierge is our pre-submission ANDA compliance product.

North Brunswick, NJ NJ Small Business Enterprise Certified
👤

Founder

A sixteen-year pharmaceutical industry veteran whose experience spans clinical development, commercial operations, and manufacturing. Doscierge encodes the pre-submission review a seasoned regulatory professional runs by hand — because the founder has watched those reviews, and their gaps, up close.

16-year industry veteran Clinical · Commercial · Manufacturing
🎯

Our mission

Every ANDA filed right the first time is a generic medicine that reaches patients sooner. We build the compliance layer that makes first-cycle-ready filings faster to prepare — independently validated by industry regulatory-affairs leaders.

🇺🇸

Reshoring-aligned

Supporting pharmaceutical reshoring and domestic manufacturing excellence. As federal policy brings API and finished-dosage manufacturing back to the US, Doscierge helps domestic filers move faster — because speed to filing is speed to patient.

Get in touch

Let's talk about your filings

No sales spam. A conversation about your submissions and what Doscierge would catch.

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