Consulting & Engineering
We convert regulatory strategy into brick-and-mortar reality:
- Clean-room design & qualification – Concept, HVAC sizing, HEPA filtration mapping, differential-pressure cascades, continuous monitoring architecture, PQ documentation
- Source identification & technical audits – On-site GMP audits, gap assessments, CAPA follow-up and supplier score-carding
- Banking & financial optimization – LC structuring, export-credit insurance, duty-drawback programs, cash-flow modeling for capital-equipment purchases
Our engineers and QA specialists speak FDA, EMA, TGA, PMDA and SFDA dialects fluently and have led dozens of successful pre-approval inspections.