A blood sample is obtained by inserting a needle into a vein in the arm. Sometimes a random urine sample, a 24-hour urine sample, or peritoneal fluid is collected.
We are experts in performing qualification activities in line with current regulatory requirements, ICH & ISO guidelines, and industry best practices.
Some of the key regulatory guidelines and standards we follow are. FDA (21 CFR Part 210, Part 211, Part 600 and Part 11) , MHRA, EUDRALEX Vol.4 (Annex 15 , Annex 11 and other applicable annexes) , ICH Q9, ISO 14644 , ISO 13485, ISO 9001, ASTM E2500 and ISPE GAMP5 guidelines.
We can provide support with the following types of Validation Activities: