The QMS Implementation Accelerator for Biotech Startups
From audit-ready documentation to expert training, we provide the essential tools to eliminate compliance delays and move your science forward.
Your Accelerator for Audit-Ready Compliance
Our templates provide a proven framework, allowing you to focus on adapting the system to your specific processes, not writing them from a blank page.
Save Hundreds of Hours
Our templates represent over 300 hours of expert writing and formatting. Reclaim your team’s time to focus on research and development.
Be Audit-Ready, Faster
Walk into your next regulatory inspection or investor diligence with a professional, comprehensive, and defensible Quality Management System.
Reduce Compliance Risk
Our templates are authored by industry experts, covering the complete range of cGMP requirements for clinical-phase manufacturing.
The Strategic Choice for Early-Phase Startups
Satisfy investor and regulatory demands now. Defer a six-figure eQMS investment until you’re ready.
The QMS Implementation Accelerator
(Our Templates)
- Fast Implementation: Establish an audit-ready QMS in weeks, not months.
- Capital-Efficient: A fraction of the cost of an eQMS, preserving capital for R&D.
- Flexible & Owned: You own and control your documents in simple MS Word format.
The Traditional eQMS Trap
(Validated Software)
- Lengthy Timelines: 6-12+ month validation and implementation projects are standard.
- High Upfront Cost: Six-figure investments in software, validation, and consulting fees.
- Rigid & Complex: Forces your agile team to conform to complex software workflows.
Limited-Time Launch Offer
Save 20% on all documentation kits and bundles to celebrate our launch.
The Complete QMS Accelerator
The entire “Quality System in a Box” to achieve audit-readiness in weeks.
One-time purchase
- 60+ Document Templates
- Includes All 9 Quality Systems
- Implementation Guide Included
- Bonus: CSV & Data Integrity Docs
System-Specific & Foundation Packs
Target a specific area of your QMS with a specialized bundle.
QMS Foundation Pack
The essential framework to start writing and controlling documents the right way.
One-time purchase
- 12+ Document Templates
- Includes QMS & Document Control
Core Quality Systems Pack
Implement Deviation, CAPA, and Change Control systems.
One-time purchase
- 9+ Document Templates
- Includes Deviation & CAPA
Equipment & Facilities Pack
Qualify, calibrate, and maintain your equipment and facility.
One-time purchase
- 11+ Document Templates
- Includes IQ/OQ/PQ & Calibration
Laboratory Controls Pack
Establish robust control over your QC lab operations.
One-time purchase
- 10+ Document Templates
- Includes OOS & Stability Programs
Integrated GMP Training Modules
Complement your documentation with our expert-developed training modules. Each course provides the necessary context to ensure your team can effectively implement and execute your quality systems.
Training: Document Control & GDP
Our first training module is now available! This 12-slide course covers the entire document lifecycle and the critical principles of ALCOA+. It’s the perfect tool to train new hires and ensure your team’s documentation practices are bulletproof.
Learn More About Training BundlesOur 30-Day Money-Back Guarantee
We are confident that this documentation kit will save you hundreds of hours. If you are not completely satisfied with the quality and comprehensiveness of our templates, simply email us within 30 days of your purchase, and we will issue a full refund.