What We Offer

Strategic GMP Solutions Built for Growth

We deliver hands-on, end-to-end support across compliance, operations, and leadership—helping life sciences companies navigate complex challenges, accelerate development, and scale with confidence. Whether you're launching a facility, preparing for inspection, or transforming your organization, our solutions are tailored to meet you where you are and take you where you need to go.

Regulatory and GMP Compliance

  • Regulatory Strategy & Guidance

  • GMP Readiness & Road Mapping

  • Phase-Approach GMP Programming

  • Supplier Audit - Technical Support

Technology Solutions

  • Vendor Oversight and Management

  • CDMO Selection Guidance

  • Process Optimization and Scale Up

  • Technology Roadmap

  • Technology Implementation Planning

GMP Facility Startup

  • CQV Master Scheduling

  • Validation Master Planning

  • Process Closure Risk Assessment

  • Contamination Control Strategy and Risk Assessments

  • CQV Service Delivery

Business Consulting

  • Organizational (re)Design

  • Organization Transformation

Fractional Leadership

  • COO / VP of Operations

  • CTO / VP of Technology

  • CQO / VP of Quality

  • CCO / VP of Sales & Marketing

Ready To Strengthen Your GMP Strategy?

Connect with our team to explore customized solutions that meet your regulatory, operational, and growth goals.