ABSTRACT
Any actions in the biopharmaceutical supply chain (BPS), regardless of their scale, scope, or breadth, are subject to regulatory requirements by various government agencies. Hence, ensuring compliance to the letter of the law remains a particular challenge for companies in the BPS. Not only are such laws changing on a regular basis, but the interpretation of these regulations are also diµcult to interpret and are subject to wide variations in what it means to be “compliant.” Further, government oµcials struggle to be able to even explain what these regulations mean. A host of consulting industries has arisen from former government regulators who have found it proŠtable to take on the task of explaining regulations to participants in the supply chain and deŠning in speciŠc and measurable terms what it means to comply with these regulations.
