McGuff Pharmacy
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 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 9001:2000 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 Trail Assessment

877.444.1133  e-mail: doug@mcguff.com

Larry Woodhouse, Pharm.D., Director of Product and Market Development    

800.854.7220  e-mail: larry@mcguff.com