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 cGMP 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 can trust.
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 do not.
Whether you are new to the pharmaceutical industry equipped with just an idea or a seasoned veteran of the industry, we are here to tailor our capabilities specific for your needs. We are here to be your partner through the product development process as your products success is our success.
As a company we have successfully developed and launched multiple products into the pharmaceutical market to include New Drug Applications, Abbreviated New Drug Applications, and Drugs to be used in Clinical Trials. Each launch is met with their own set of challenges and intricacies that our seasoned team will met head on for you. Rest at ease knowing that you are good and capable hands.
Quality Assurance and Control is paramount at our facilities as the safety of the public is at the pinnacle of importance. Our quality systems, which were developed, around Current Good Manufacturing Practices among many others, to ensure the safe delivery of a drug to a patient is in need. We set our quality levels high and are able to sleep soundly at night.
In depth and diverse internal lab capability on premise. Some of the testing capabilities includes microbiology testing, water for injection testing, incoming raw material testing, finish product testing, clean room environment testing, sterility, chemistry and physical testing. We also have established relationships with local laboratory testing facilities for any other unique tests that may need to be run.
Current Good Manufacturing Practices (cGMP)
Drug Supply Chain Security Act (DSCSA)
Product/Lot level Tracking Compliance
Serialization Tracking Compliance
Dedicated marketing team at your disposal with decades of experience in the pharmaceutical market for branding, messaging, pricing, and taking your product to market. Experts in everything you need to take your product to the market segment of your choosing:
Department of Veteran Affairs
Defense Logistics Agency
Dedicated wholesale distributor licensed for national and international sales force and distribution direct to the customer or to other wholesalers in the market segment. No matter what the means of distribution for your product is needed, we are able to provide the solution.
Distribution to Major Wholesalers
Third Party Logistics (3PL)
Direct to Consumer
Private Wholesale Distributor