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Home >> About PBL >>Quality Systems >> Regs and Standards

QUALITY SYSTEM: Regulations and Standards


The following link takes you to a company that has translated some ISO standards into Plain English:


The following link takes you to the Internationals Standards Organization where you can immediately purchase the actual standards:


Here are links to FDA regulatory standards that apply to Quality Assurance or Quality Control. This is certainly not all the regulations with which PBL is familiar or that we can accommodate. Our customers most frequently request help for these requirements.

If you are making a drug or pharmaceutical, this link takes you to the cGMPs (21CFR211):


If you are making (or want to make) a biological product, this link takes you to the FDA Quality requirements (21CFR610):


If you are making (or want to make) a medical device, this link takes you to the FDA Quality System Requirements (QSR 21CFR820):


If you are haven’t made any products yet, but want to have the FDA approve them, here is a link to the FDA requirements for Good Laboratory Practices (GLP  21CFR58):


If you would like to learn more about the FDA's guidance for inspections and field activities, you can find information at the following link.



Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.

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