Regulatory and GMP Compliance

GMP Facility Startup

Technology Solutions

Fractional Leadership

Regulatory Strategy & Guidance

GMP Readiness & Road Mapping

Phase-Approach GMP Programming

Supplier Audit - Technical Support

CQV Master Scheduling

Validation Master Planning

Process Closure Risk Assessment

Contamination Control Strategy and Risk Assessments

CQV Service Delivery

Vendor Oversight and Management

CDMO Selection Guidance

Process Optimization and Scale Up

Technology Roadmap

Technology Implementation Planning

Organizational (re)Design

Organization Transformation

COO / VP of Operations

CTO / VP of Technology

CQO / VP of Quality

CCO / VP of Sales & Marketing