Why Choose McGuff
Our current FDA Inspection Classification is "No Action Indicated (NAI)".
An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
At McGuff Pharmaceuticals, we listen to you first. Success of any outsourcing project
depends on a close, flexible relationship between both parties at the highest levels
to achieve mutual success. We have a proven capability of developing a process that
is robust, transferable, and scalable to meet your contract manufacturing requirements.
We focus on quality and compliance. These topics are now "top of mind" across the
industry. The bar is being set higher for every pharmaceutical manufacturer and
especially sterile fill pharmaceutical manufacturers. FDA and EMA have created a
working environment that is witness to daily changes in regulations and guidelines
resulting in increased costs and pharmaceutical plant closures.
McGuff Pharmaceuticals has a well-established facility and standard operating procedures
to meet both cGMP and ISO 9001:2008 requirements. Our policies and procedures encompass
all of the training, validation, manufacturing and testing that provide our drug
manufacturing outsource customers a cohesive regulatory compliance environment they
As your contract manufacturing organization, McGuff Pharmaceuticals can leverage
its capital investment and investment in human resources to reduce your cost, time-to-market
and risk to bring a new drug to market or to maintain your current product.
McGuff Pharmaceuticals can also provide our knowledge in regulatory affairs and
the facility/production capability to submit ANDAs on your behalf.
McGuff Pharmaceuticals is much more than a "white powder, white pill" Contract Manufacturing
Organization. We offer many services that other Contract Manufacturing Organizations
Learn more about the contract manufacturing services we provide.
We are here to help. Let us show you how.