Request Readiness Review

Submission requirements

See what a reviewer will ask you for.

Pick your product category and target region. This is the evidence structure DSRV works from, section by section, with the regulation or guidance behind every line. No account, no upload, no readiness grade.

Product category

Submission region

Gels (topical semisolids) · United States (FDA)

11 sections · 56 evidence items

Citations are regulatory anchors for orientation, not an exhaustive or binding checklist. DSRV's reviewer confirms applicability to your specific product and submission type.

  1. Section 01

    Product Overview

    • FDA21 CFR 314 (NDA/ANDA content) — application context

    • Product profile (name, dosage form, strengths)

    • Market / region target

    • Submission type

    • Client owner / contact

  2. Section 02

    Raw Materials & Components

    • FDA GMP21 CFR 211 Subpart E — control of components
    • ICHICH Q8(R2) §2.1 — material attributes

    • API information

    • Excipients

    • Packaging components

    • Supplier / vendor documents

    • Certificates of analysis

    • Material specifications

  3. Section 03

    Manufacturing Process

    • FDA GMP21 CFR 211 Subpart F — production and process controls
    • ICHICH Q8(R2) §2.3 — process development

    • Process description

    • Master production / control record references

    • Manufacturing flow

    • Critical process parameters

    • Equipment / process notes

    • In-process controls

  4. Section 04

    Specifications & Methods

    • ICHICH Q6A — specifications and acceptance criteria
    • USPApplicable USP general chapters (e.g. <711> dissolution)

    • Finished product specifications

    • Raw material specifications

    • Analytical methods

    • Method validation / verification documents

    • Acceptance criteria

    • Rheology / viscosity specification and method

  5. Section 05

    Batch Records

    • FDA GMP21 CFR 211.186/.188 — master and batch production records

    • Executed batch records

    • Master batch record

    • Deviations / investigations

    • Batch disposition / release records

  6. Section 06

    Validation & Verification

    • FDAFDA Process Validation Guidance (2011) — stages 1–3
    • ICHICH Q2(R2) — analytical method validation

    • Process validation

    • Cleaning validation (if applicable)

    • Method validation / verification

    • Equipment qualification references

    • Continued process verification

  7. Section 07

    Test Results & Quality Data

    • FDA GMP21 CFR 211 Subpart I — laboratory controls; 211.192 — OOS review

    • Finished product test results

    • Raw material test results

    • In-process test results

    • OOS / OOT investigations

    • Data tables / structured result uploads

    • Microbial limits test results

    • In-vitro release testing (IVRT)

  8. Section 08

    Stability & Shelf-Life Evidence

    • ICHICH Q1A(R2) — stability testing of new drug substances and products

    • Stability protocol

    • Stability pulls / intervals

    • Stability results

    • Trend summaries

    • Shelf-life justification

  9. Section 09

    Safety / Suitability / Risk Evidence

    • ICHICH Q9(R1) — quality risk management

    • Quality risk assessment

    • Impurity / degradation risk

    • Safety support documents

    • Product quality rationale

  10. Section 10

    Labeling & Packaging Evidence

    • FDA GMP21 CFR 211 Subpart G — packaging and labeling control

    • Label copy

    • Packaging specifications

    • Artwork / control records

    • Packaging batch evidence

  11. Section 11

    Submission Readiness Review

    • DSRVDSRV submission-readiness review gate

    • Completeness checklist

    • Missing items

    • Reviewer comments

    • Client action items

    • Readiness status

What happens next

Nothing here needs a document from you

This list is the starting structure, not a verdict on your programme. Evidence only moves into a private, engagement-scoped workspace after confidentiality scope is agreed, and a DSRV reviewer confirms which items actually apply to your product.