We help pharmaceutical, nutraceutical, and cosmetic manufacturers streamline compliance documentation, reconcile legacy systems, and scale operations with confidence—preventing conflicting requirements before they become costly problems.
Combining deep regulatory expertise with AI-powered document generation, we deliver compliant policies and procedures in days, not months—with the consistent quality and technical accuracy only human SME oversight can guarantee.
Start Your Compliance JourneyStarting from scratch or building out your quality system? We create complete, industry-compliant policies and procedures tailored to your operations. AI accelerates document creation while our regulatory SMEs ensure technical accuracy and compliance—delivering professional documentation with consistent formatting in a fraction of traditional timeframes.
AI-powered analysis evaluates your entire documentation ecosystem to identify conflicts, contradictions, and gaps between procedures. We map dependencies across thousands of pages to reveal where documents contradict each other or fail to align—issues that could derail audits or operations.
Our SMEs conduct comprehensive reviews of your product lifecycle documentation against current industry standards and regulatory expectations. We identify where your processes diverge from best practices and provide actionable recommendations to bring antiquated procedures up to modern compliance standards.
Technical evaluation of project deliverables including Basis of Design (BOD), validation plans, protocols, schedules, and reports. We ensure your project documentation meets regulatory requirements and industry standards before submission—preventing costly rework and delays.
Facing an imminent audit or event? Our rapid-response service generates compliant stopgap protocols within 24-48 hours. AI-accelerated drafting combined with immediate SME review provides emergency documentation that meets regulatory scrutiny—buying you time to implement permanent solutions.
Overwhelmed by investigation backlogs? We evaluate your open investigations and provide structured analysis: identifying information gaps, conducting impact assessments, performing root cause analyses, and recommending evidence-based dispositions. Get your backlog under control with clear, defensible conclusions.
Drug manufacturers navigating FDA regulations, cGMP requirements, and validation documentation challenges.
Dietary supplement companies balancing FDA oversight with evolving industry standards and quality expectations.
Beauty and personal care manufacturers ensuring compliance with cosmetic regulations and quality standards.
✓ No functioning quality system in place
✓ Procedures haven't been updated in years
✓ Documents contradict each other
✓ Staff struggle to follow current SOPs
✓ Audit findings reveal documentation gaps
✓ Expanding operations need documentation support
We've helped manufacturers just like you transform documentation chaos into compliance confidence.
Whether you're establishing your first quality system, struggling with outdated documentation, or discovering conflicts between procedures, Validation Labs delivers the expertise and efficiency you need.
Many manufacturers in pharmaceutical, nutraceutical, and cosmetic industries face the same challenge: compliance documentation that's either non-existent, antiquated, or riddled with contradictions. Traditional consulting is slow and expensive. DIY approaches lack technical depth and consistency.
Our hybrid model combines the speed of AI-generated documentation with the judgment of experienced regulatory SMEs. The result? Professional, compliant policies and procedures delivered in days with consistent formatting, technical accuracy, and the regulatory defensibility required for successful audits.
AI generates compliant documentation in days, all reviewed and validated by regulatory SMEs
Professional formatting and terminology across all documents—no more patchwork quality systems
Deep knowledge of pharmaceutical, nutraceutical, and cosmetic regulations
A client needed a comprehensive Basis of Design (BOD) for a fill-finish facility producing terminally sterilized 0.9% sodium chloride solution in 3cc plastic vials. Timeline was critical—they needed detailed facility specifications quickly to move forward with capital planning.
Our AI system generated an incredibly detailed, professionally formatted BOD in hours—complete with equipment specifications, process flows, utility requirements, and quality control strategies. The document was comprehensive, technically sophisticated, and appeared ready for implementation.
Depyrogenation Tunnel Specified — The AI included a high-temperature depyrogenation tunnel in the design, a standard approach for glass vials. However, this equipment would have melted the plastic vials, rendering the entire system useless. Estimated cost impact: $500K+ in unusable equipment.
ISO Class 5 Filling Area — The design called for ISO Class 5 cleanroom conditions for the filling operation. While this exceeds regulatory requirements, it's unnecessary for terminally sterilized products where only ISO Class 8 is required. Cost impact: Additional $200K+ in infrastructure and operational costs.
Material Compatibility Oversights — Several equipment specifications didn't account for the specific constraints of plastic vial handling and terminal sterilization validation requirements.
Our experienced pharmaceutical engineer immediately recognized these critical incompatibilities during review. Within hours, we corrected the design to:
• Replace the depyrogenation tunnel with appropriate plastic vial handling and preparation systems
• Right-size the cleanroom classification to ISO 8, reducing capital and operational costs
• Specify equipment compatible with terminal sterilization validation requirements
• Adjust material flow and sterilization approach to match plastic vial constraints
AI provides incredible speed and comprehensive coverage that would take human consultants weeks to produce. But without deep industry expertise, AI can confidently specify systems that simply won't work. Our model harnesses AI's efficiency while ensuring every deliverable passes through experienced SME review—catching costly errors before they become expensive mistakes. You get the speed of AI with the precision only human expertise can guarantee.
Let's discuss how Validation Labs can help your organization navigate regulatory requirements with confidence and clarity.
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