TECHNICAL CONSULTING EXCELLENCE

Accelerate Innovation in Regulated Industries

Combining pharmaceutical rigor with cutting-edge technology to deliver validation solutions that are faster, more efficient, and more reliable than traditional approaches.

Unmatched Expertise & Innovation

We're the validation and automation consultancy that combines pharmaceutical rigor with technology innovation. While traditional consultants follow outdated methodologies, we bring cross-industry best practices.

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Cross-Industry Innovation

We bring best practices from pharmaceutical, medical device, biotech, and IT industries to solve your specific challenges with proven solutions from adjacent sectors.

Accelerated Results

Our agile compliance methodology delivers validation results significantly faster than traditional approaches while maintaining full regulatory compliance.

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Senior-Level Expertise

Unlike large consulting firms that assign junior staff, you work directly with senior experts while paying boutique firm rates that beat big firm pricing.

Comprehensive Technical Consulting

End-to-end services for regulated industries, delivering innovation with compliance excellence.

01

Commissioning, Qualification & Validation

Complete CQV services for manufacturing equipment, utilities, and facilities. From design qualification through performance qualification, ensuring regulatory compliance.

02

System Validation

Comprehensive validation of computerized systems, laboratory instruments, and manufacturing execution systems. Ensuring 21 CFR Part 11 compliance and data integrity.

03

Process Automation

Design and implementation of automated manufacturing processes, control systems, and Industry 4.0 solutions for regulated environments.

04

FDA Compliance Solutions

Navigate complex FDA regulations with confidence. Compliance assessments, gap analyses, and remediation strategies for pharmaceutical and medical device manufacturers.

05

Data Integrity & ALCOA+

Implement robust data integrity programs that meet regulatory expectations. Ensuring data is Attributable, Legible, Contemporaneous, Original, and Accurate.

06

Digital Transformation

Modernize operations with cloud-native solutions, AI-enhanced validation, and digital twin technologies while maintaining GxP compliance.

Industries We Serve

Pharmaceutical Manufacturing Medical Device Biotechnology Cell & Gene Therapy Contract Manufacturing Digital Health Diagnostics Clinical Research

Setting New Standards in Validation

Our mission is to accelerate innovation in regulated industries by combining pharmaceutical rigor with cutting-edge technology.

Next-Generation Validation

  • AI-enhanced validation and risk assessment
  • Cloud-native compliance solutions
  • Automated documentation generation
  • Real-time monitoring systems
  • Digital twin validation models

Agile Compliance Methodology

  • Phased validation approach
  • Risk-based validation strategies
  • Continuous improvement integration
  • Stakeholder collaboration
  • Regulatory pre-engagement

Complete Lifecycle Management

  • Design-for-validation approach
  • Implementation support
  • Change control integration
  • Ongoing compliance monitoring
  • Technology evolution planning

Speed

We deliver results while large firms are still assembling teams. Our streamlined processes mean faster project completion without compromising quality.

Cost Efficiency

Senior expertise without enterprise markup. Direct access to principal consultants, not junior analysts managed by distant partners.

Innovation

Modern technology integration vs. outdated methodologies. Broader perspective vs. single-industry tunnel vision.

Strategic Value

Business strategy integration vs. just compliance checking. We align validation activities with your business objectives.

Specialized Expertise in High-Growth Sectors

Cell & Gene Therapy

Specialized manufacturing and quality systems validation

Digital Health

Software validation, cybersecurity, and data integrity

AI/ML Medical Devices

Algorithm validation and regulatory compliance

Automated Manufacturing

Industry 4.0 compliance in regulated environments

Continuous Manufacturing

Real-time release and process validation

Ready to Accelerate Your Validation Projects?

Let's discuss how we can help you achieve compliance faster and more efficiently.

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Our Location

Votion Solutions LLC
New York, NY
United States

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Email

info@votionsolutions.com

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Phone

Business Line: Available upon request
Response within 24 hours

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Project Inquiries

We respond to all inquiries promptly
Free initial consultation available

Start Your Project Today

Contact us for a free consultation and discover how we can accelerate your validation projects while reducing costs and ensuring compliance.

Professional. Efficient. Compliant. Innovative.

Contact Us Now