The IRS has provided procedures (Rev. Proc. 2018-60) under which a taxpayer may obtain automatic consent to change a method of accounting to comply with Sec. 451(b), as amended by the law known as the ...

In the world of business, methods of organization can be used to convey an idea, relay information, assemble a procedure and seal a deal. Methods of organization create order and direct the thoughts ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.