We offer end-to-end full-lifecycle consulting and planning services for cGMP pharmaceutical and bioprocessing facilities, covering every stage from pre-investment evaluation to post-operation regulatory support. Our team of pharmaceutical engineers, GMP compliance specialists and validation consultants delivers risk-based planning aligned with FDA, EMA Annex 1, PIC/S and ISPE guidelines, serving biologic, vaccine, small-molecule and cell therapy manufacturing projects.
Our full-cycle service portfolio includes site selection & feasibility study, user requirement specification (URS) formulation, gap analysis for existing plants, master layout planning, cleanroom classification design, utility system scheme optimization, construction phase technical supervision, CQV consulting, regulatory audit preparation, and post-handover operational optimization. Whether you plan a new greenfield factory, modular cleanroom pilot plant or GMP renovation of legacy workshops, we customize compliant planning schemes to match your production scale, product pipeline and long-term expansion demands.
We resolve core pain points including unreasonable process flow, hidden contamination risks, non-compliant utility layouts and insufficient audit documentation. By embedding GEP and cGMP requirements in early-stage planning, we avoid costly late-stage design modifications, control overall project investment, and help clients build audit-ready production facilities that pass global official inspections efficiently.
