PharmaDocs AI reads the method, column, wavelength and acceptance limits straight off your STP, then drafts the AMV Protocol, Report and Calculation Sheet — company header, numbering and signatory blocks already in place.
Assay of Aripiprazole Tablets 15 mg · HPLC with internal standard
| Parameter | Acceptance criteria | Observed |
|---|---|---|
| Tailing factor | NMT 2.0 | 1.12 |
| Theoretical plates | NLT 2000 | 8642 |
| %RSD, six replicates | NMT 2.0 % | 0.43 % |
Drag and drop a DOCX or PDF. The system accepts Standard Test Procedures, Specifications, and method documents in any standard pharmaceutical layout.
The AI reads every field — product, strength, method, wavelength, column, and acceptance criteria. Edit any value before you proceed.
Choose what to generate. Each file downloads as a formatted DOCX with your company header, licence number, and signatory blocks pre-filled.
PharmaDocs AI takes on the repetitive, error-prone parts of validation documentation, so your analysts spend their time on the science instead of formatting tables and chasing signatures.
Upload Standard Test Procedures or Specifications as DOCX, PDF, or scanned images. The system extracts product, strength, method, specification limits, and acceptance criteria — no manual copy-pasting.
AMV Protocol and Report, Related Substances, Process Validation, ICH stability, and forced degradation. Each is structured around ICH Q2(R2) validation parameters with numbered sections, data tables, and signature blocks.
Company name, registered address, and logo appear in every document header automatically. Set it once in Settings and every document you generate after that carries it.
Upload signature images for each team member and assign Prepared, Reviewed, and Approved roles. Signatures print in the correct blocks in every generated document.
Maintain a master list of instruments with calibration dates, reference chemicals, and working standards. Pick the ones used for a study and they populate the relevant validation sections, no retyping.
Pro and Enterprise subscribers generate API keys and call our endpoints directly — pull extracted data, trigger generation, and download files without opening a browser.
Assay validation, related substances, process validation, and stability. If your quality department documents it, the platform drafts it.
No contracts. No per-seat pricing. Cancel any time.
PharmaDocs AI is built by Ashab Group, a pharmaceutical trading and regulatory consultancy serving 60+ countries with a portfolio of over 6,000 registered pharmaceutical products.
The platform grew out of that day-to-day work: preparing analytical method validation, process validation, and stability documentation for export dossiers across the EU, the Americas, and Asia-Pacific. We turned the templates and review checks our own teams relied on into software.
Create a free account, upload an STP, and download your first AMV Protocol and Report today. No credit card, no sales call.