Why Choose McGuff
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
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.
We are here to help. Let us show you how.