Services

Regulatory Affairs:

Health Canada as the reference enterprise for the ZAYMEX™ has identified the expedited access for the Disinfectants during the COVID-19 (RA-72623). For the final DIN registration no and upon the approval of PMF (ITA/MDL) we will submit ZAYMEX™ in Health Canada. The EPA, US and European CE Mark will be the next TBD steps. In case of ZAYMEX™ (WW360H) wound wash we need to apply for the FDA (PMA/510K) throughout MDB/CDHR gateways as well. ZAYMEX™ complies with the Canadian PIDAC Best Practices rules and regulation.

Scale-Up Manufacturing

Scale-Up Manufacturing: Having been utilized a phase by phase manufacturing scale-up ZAYMEXCanada will develop semi-automated RO-DIW and the Mixing , Dispensing and Packaging units to the fully automated one. A Class-10,000 clean-room site plant is considered to be ZAYMEXCanada site plant. The Q/A, Q/C, Labs, Supply Chains, Logistics and Inventories departments and Marketing and Sales will cooperate in accordance with the Business Development and Leadership Action Plans. To improve ZAYMEX™ a High Level Disinfectant (HLD) we need to compromise the manufacturing and quality control plan with ISO 9001, 13485, 14971 and GMP standards. All the SOPs will be verified and validated according to the GMP standards.