03 · How we do it
Five phases, from policy to a working system.
Each phase is designed with the next in mind, so the program moves without stalls between ministries, operators, and manufacturers. How we build an operation, stage by stage ↗
01Policy & framework
National plasma policy, regulatory framework, donor protection, and supply targets.
02Donor program & collection network
Donor recruitment and care, center locations, capacity, and the operating model.
03Quality system & regulatory pathway
A quality system built to FDA, EMA, MHRA, and MHLW/PMDA expectations, with national authority approval.
04Fractionation pathway
Contract or toll fractionation first, with a route to domestic manufacturing where it makes sense.
05Workforce & handover
Training, leadership, and governance, so the system runs and improves without us.
Global standards, local execution
FDAUnited StatesEMAEuropean UnionMHRAUnited KingdomMHLW / PMDAJapan
Across the Middle East, Africa, Latin America, and Southeast Asia, we design to the expectations of the world’s most demanding regulators so plasma can qualify for international fractionation. National authorities keep the final decision on licensing and approval.