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. We recognize each clinical trial has unique requirements that in some cases may vary greatly from the norm. We have a proven methodology to assist sponsors to define, organize and execute a process to meet their needs.
We offer the ability of developing internal processes that are robust, transferable, and scalable to meet the unique needs of the clinical trial.
Whether the goal is a successful clinical trial to support a New Drug Application, IND, preclinical or clinical submission, each project large or small requires a unique and well thought out strategy. Each strategy needs to be defined to assure success. Large or small projects involve selection of different regulatory and quality strategies at different levels. Usually a strategy consists of well-sketched tactics to accomplish customer goals. Each of the strategies we offer has pre-calculated results because when a particular strategy is chosen at a particular level, its outcome can be leveraged. A reasonable strategy should not only facilitate goal achievement, but also define the action sequence and incorporate efficiencies within a campaign.
McGuff Pharmaceuticals, working independently or with its Alliance Partners; McGuff Compounding Pharmacy Services, Inc. and McGuff Company Inc. (a medical products distribution company) can resolve many regulatory and product issues pertaining to clinical trials.
McGuff Pharmaceuticals provides the core competency of FDA current good manufacturing practices and cGMP clinical trial requirements.
McGuff Compounding Pharmacy Services provides the flexibility of large or small scale production, pharmaceutical dispensing and cGMP compliance if needed. The compounding pharmacy adds the knowledge of having produced drugs of all types and for almost all routes of administration. This experience can be critical in areas of clinical trial development and execution.
McGuff Medical Products Company provides warehousing and distribution services for clinical trial support.
Our combined management team has extraordinary experience in clinical trial development. Senior management expertise includes; Pharmacology, Biochemistry, Microbiology, Engineering, Analytical Chemistry, Pharmacy, Information Technology, Business Management and other related technologically demanding disciplines.
McGuff Pharmaceuticals maintains FDA reviewed microbiology and chemistry labs to support our pharmaceutical research and development. We also use our microbiology and chemistry labs to assist our contract drug manufacturing and clinical trial customers when needed.
Everyone has great ideas, however it is those that are able to take their great idea from a concept to a reality that truly make a difference.
Pharmaceutical product development companies are a dime a dozen. However a pharmaceutical product development company that is able to take you from an idea, develop it into a physical product, and then get the product into the hands of a customer is a whole other story. We are that company. We have many years of experience in product development, manufacturing, and the connections within the market for end to end distribution. We have many success stories of products that we have developed and launched into the supply chain with the major wholesalers/distributors whether you are selling to Hospitals, Pharmacies, Group Purchasing Organizations (GPO), Government Agencies, and to Private Practice Physicians.
We are committed to the success of your clinical trial even before we sign an agreement.
We understand what is at stake for your organization and how dependent you are on your contracted vendors to perform. We also recognize your time is valuable.
We promise to provide truthful answers to all your questions. We promise to be honest in our evaluation of ourselves and our ability to successfully meet your requirements. If we believe we are unable to provide you with outstanding service you deserve, we will say so up front.
After initial discussions, it is our desire that you come to our facilities for further discussions and audit. We want our clinical trial investigators and sponsors to understand our level of commitment first hand. We also want you to be absolutely sure of our people, their expertise and ability to help.
No questions should remain unanswered. Your confidence in us must be based on an understanding of who we are and how we operate.
We are here to help. Let us show you how.
Our drug products are manufactured using validated processes and equipment while following exacting standard operating procedures. Our manufacturing and quality assurance organizations have developed strict controls to ensure product integrity and accountability. In addition, products are tested and released using formal specifications and validated analytical methods.
The Quality Assurance organization also maintains an on-site testing laboratory to ensure that our drug products meet established standards and perform to our high expectations. We have validated methods for microbiological, biological, chemical and physical tests and product assays.
Our Quality Assurance organization performs internal audits of operations, as well as external audits of contract laboratories, raw material and component manufacturers. These audits assure that our outsourcing partners maintain well-established standard operating procedures, training, validation, testing systems, and provide a cohesive regulatory compliance environment that meets McGuff Pharmaceutical's high quality standards.
The Regulatory Affairs organization at McGuff Pharmaceuticals ensures that any operations to be conducted are designed in compliance with regulatory requirements as specified by the FDA and/or other regulatory agencies. Ongoing review of operations assures that projects continue to maintain compliance with the current regulatory environments.
This merging of organization, facilities and regulatory focus allows us to provide quality products to the health care community.
If the clinical site investigator does not have a properly maintained drug at the time the patient is required to receive it, the whole trial may be at risk.
McGuff Pharmaceuticals has the experience and the facilities to deliver critical supply chain management. It does not matter if your drug requires next day delivery, requires to be frozen, refrigerated or ambient temperature… we can handle it.
The cost of supply chain custody and management may become one of the major cost centers of a clinical trial depending on the drug’s characteristics. It is our desire to reduce these costs while mitigating risks.
McGuff Pharmaceuticals provides the following supply chain management solutions:
Collectively, we have provided or assisted clinical trial services for sponsors large and small. Here are a few of the sponsors we have served: