Quality & Regulatory Consulting
Our Approach
We deliver practical, science-based, and risk-based solutions grounded in how regulators actually inspect and enforce cGMP requirements…not just how they are written. Our approach aligns with FDA, EMA, and ICH expectations while strengthening product quality, sterility assurance, and data integrity.
We build scalable, inspection-ready systems that support clinical progression through commercial readiness, embedding compliance directly into facilities, operations, and workflows…not just SOPs.
Whether launching a new facility, preparing for inspection, remediating gaps, or scaling operations, we provide focused, confidential assessments to move you forward with confidence.
Core Quality Consulting Services
Quality Management System Design
Quality Manuals
SOP authoring
Batch Records /Compounding Records
Training programs
Deviation, CAPA, and change control
Environmental Control
Cleaning and Environmental Monitoring program design
ISO 5/7/8 classification strategy
Sampling plans and alert/action levels
EMPQ
EM trending and excursion investigations
Sterility Assurance & Aseptic Controls
Facility flow and segregation risk assessments
Aseptic process simulation, and media-fill strategy
Cleaning and disinfection optimization
Phase-Appropriate cGMPs