Clinical Trial Services


McGuff Pharmacy Main Page	Clinical Trial Services McGuff employs pharmacists, engineers, regulatory affairs and other personnel that have experience working in hospital, community settings, the chemical industry, and commercial pharmaceutical manufacturing. We provide services for Clinical Trial Phases 1, 2 and 3 by utilizing our compounding pharmacy and/or our FDA reviewed, cGMP compliant manufacturer. Examples of services provided include: Design and custom compounding or manufacturing of active and placebo drug dosage forms Assemble clinical trial patient kits & documentation including Drug preparation Patient information sheet Informed consent Process validation including Aseptic fill processes Sterilization processes Filtration processes Depyrogenation processes Batch compounding processes Patient tracking Blinding or open labeling of study drug Randomization of enrolled subject Validation of testing methods Endotoxin Sterility Finished product potency testing Investigational New Drug Application support documentation and consultation Examples of various final dosage forms prepared include: Parenteral: sterile injectable products (aqueous or oil base) in vials, syringes, bottles, or bags Oral: capsule, oral liquid, oral suspension Topical: solution, cream, ointment, gel Rectal: Suppository Qualifications of McGuff CPS and McGuff Pharmaceuticals Clinical Trial: University of California, Los Angeles (UCLA); University of California, Irvine (UCI); Long Beach Memorial Medical Center and others Certificates: American National Standard; ISO 9001:2008 Quality Systems-Model for Quality Assurance Inspections: California State Board of Pharmacy, FDA McGuff Pharmaceutical, Inc. is FDA-registered and cGMP compliant McGuff Compounding Pharmacy operates under USP Chapters <795>, <797> and <1075> Dedicated personnel for clinical trial support: Pharmacists Engineering staff Regulatory affairs staff Laboratory: Microbiology, Chemistry and Engineering Testimonials: The reason[s] for choosing McGuff Co. as the study drug provider for the FASTMAG trial included demonstrated expertise in preparation of clinical trial products, ISO and FDA/cGMP credentialing, high level of professionalism, flexibility and innovation in addressing the specific requirements of our trial, and responsive customer service. ~Jeff Saver, MD, UCLA Neurology On behalf of the FAST-MAG Central Coordinating Center, I would like to say thank you to the entire McGuff team for your continuing efforts, achievements, and hard work.~Adrienne Binning, RN FASTMAG, Trial coordinator Contact information: We would be happy to discuss your specific needs, and make arrangements for you to tour our facilities. Please do not hesitate to contact us for additional information. Of course, information that you provide to us will be kept strictly confidential. Doug Tran, Pharm.D., Manager of Clinical Trial Assessment 1-877-444-1133 e-mail: doug@mcguff.com

McGuff Compounding Pharmacy Services, Inc. • 2921 West MacArthur Blvd., Suite 142 • Santa Ana, CA 92704 •
Telephone: 877 444-1133 • Fax: 877 444-1155 •
Info: pharmacyanswers@mcguff.com

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