With our veteran and vibrant validation execution team, we are capable to provide a one-stop service for your plant from consulting to your validation systems, also assist your validation team to upgrade continuously so as to well accept for NMPA, FDA, EMA, PIC/s, TGA, WHO-PQ GMP inspections and inspections from other territories.
Guiding for validation SOPs new drafting or upgrading as per customer’s internal GMP requirements and also with reference to NMPA, FDA, EMA, PIC/S and TGA guidelines.
Suggestions for validation related key position set up and candidate qualifications according to the current and future developments needs of the pharma.
Assist in formulating validation strategies based on risks assessment to ensure compliance with NMPA、FDA、EMA、PIC/s、TGA, WHO and other relevant regulations, as well as applicable for the pharma’s operation needs.
Different level of supports: providing SOPs template, reviewing/formulating SOPs list, guiding customer to draft or drafting SOPs directly on behalf of customer.
Provide solutions for the full life cycle of the MAH system