The Challenge: A pilot plant and large-scale commercial facility (10,000L bioreactors) needing to meet US, Chinese, and European compliance standards at once.
How Pharmatech Helped: Conducted a detailed design review for FDA, China NMPA, and EU compliance; confirmed changes directly with MHRA; delivered a cost-benefit analysis, validation lifecycle SOPs, and engineer training.
The Result: Significant design improvements delivered with zero impact to the original project timeline.
