Complete URS, DQ, IQ, OQ, PQ & SOP documentation packages for pharmaceutical, HVAC, and cleanroom equipment manufacturers exporting to regulated markets.
You've built reliable, affordable equipment. But when your buyer's auditor asks for the IQ/OQ/PQ dossier — you don't have it. The deal stalls. Your competitor with documentation wins.
Regulated markets (pharma, biotech, cleanroom, healthcare) require documented proof that every piece of equipment meets GMP, PIC/S, or WHO standards before it can be used. Without a qualification package, your equipment is literally unselable.
We had a Chinese HVAC unit held at customs for 3 months because the buyer's QA team couldn't validate performance specs. The factory had no qualification docs. — Equipment importer, Karachi
Lost Pharma & Biotech Contracts
75% of pharma buyers require IQ/OQ/PQ before purchase consideration
Price Pressure from Unregulated Markets
Commodity pricing instead of premium equipment positioning
Regulatory Delays & Customs Holds
Shipments delayed while buyers scramble to validate internally
Dependence on Buyer's Capabilities
You rely on distributors who lack documentation skills
Each package is tailored to your equipment specifications and your target market's regulatory requirements.
For pharmaceutical & biotech production equipment
For cleanroom HVAC, water systems, and utility equipment
For cleanroom equipment, lab instruments, and testing gear
Add-on: Validation Summary Reports, Training Materials, and Site Acceptance Test (SAT) protocols available at $500 each.
Equipment datasheets, drawings, and target market requirements
Full qualification package in GMP-compliant format with regulatory references
One round of revisions included. We incorporate your technical feedback.
You get signed-off PDF + editable source files. Ready to attach to every quote.
Our documentation follows international standards accepted by regulators worldwide.
Pharmaceutical manufacturing equipment (tablet presses, coating pans, mixers, granulators, filling lines), HVAC systems (AHUs, chillers, boilers, cleanroom air handling), water systems (purified water, WFI, storage/distribution), cleanroom equipment (laminar flow hoods, isolators, biosafety cabinets), and laboratory instruments (HPLC, GC, dissolution testers, stability chambers).
Standard delivery is 5-7 business days. We can expedite to 3 days at a 25% premium. Rush orders depend on current queue.
Yes — we need equipment datasheets, P&IDs (if available), and functional specifications. The more detail you provide, the more accurate the qualification. If you only have basic specs, we can work with that and flag assumptions for your review.
We tailor each package to your target market's regulatory framework — PIC/S (Europe/Asia), WHO (developing markets), or FDA (US). Tell us where your equipment is going and we'll align the documentation accordingly.
Yes. Contact us and we'll share a sample qualification package (TOC + one completed section + a blank template) so you can evaluate the quality and format before committing.
Signed-off PDF for submission, plus editable Word/Excel source files so you can modify for future projects or translate into other languages.
Send us your equipment specs and target markets. We'll respond with a package quote and a sample template within 24 hours.
Confidential review. No obligation. Free sample template on request.