Can you provide regulatory approvals/certification/authorization, etc., (if any) of your testing laboratories to perform the studies (i.e., OEL/ADE)?
According to the EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" the identification of critical effects should be based on a comprehensive literature search in handbooks, monographs, electronic scientific databases. There is no requirement for independent "testing' by a certified laboratory. For each compound, Affygility Solutions searches over 30 different scientific databases and journals.
