Research and Lab Animals
“It has been a great pleasure to work with you and your colleagues during the past six years. You provided critical, seamless support to this study. It is also because of your professionalism and experience that we successfully got to the end. So, thank you. I will certainly keep you in mind should another opportunity to collaborate with you arise.” Emilia Bagiella, Associate Professor of Clinical Biostatistics, Columbia University Mailman School of Public Health.
Research scientists have unique needs.
Clinical trials, investigational and translational research, and the veterinary care of research animals place unique demands on you — and your service providers. Your research demands sophisticated customization, quality-control and documentation services, in volumes that may be far too small for contract manufacturers — and far too large for pharmacies that do not have the technical sophistication, equipment, quality control and turnaround time that scientific research requires. Your animals need study and maintenance medications, delivered in a way that is stress-free for you and for them.
Wedgewood Pharmacy is positioned perfectly to serve your needs as a research professional who works with human and animal subjects. We are one of the largest compounding pharmacies in the United States, and we dispense custom-compounded preparations to more than 25,000 prescribers and their patients in human and animal health. And we know how to meet the needs of doctors and scientists like you. If you want to speak with someone right away about your needs, call Melissa Buggy, research account specialist, at 856.832.1351.
Wedgewood Pharmacy is a unique resource for research scientists, at the bench or bench-to-bedside.
Because of this experience and capabilities, we are a unique resource for ...
- Medical schools and teaching hospitals;
- Veterinary schools; and
- Universities and research institutions
... that are conducting clinical trials, investigational and bench-to-bedside drug studies to study the novel uses of drugs and translate new knowledge into clinical applications. Veterinarians also turn to us for the custom-compounded medications they need to maintain large research-animal populations.
By investing tens of millions of dollars in facilities, equipment and expertise since 1981 and through our own pioneering dosage-form developments, we are positioned to be your full-fledged partner in clinical trials, investigational and translational research1 and in the veterinary care of your research animals.
Your unique requirements are perfectly matched by our facilities, equipment, capabilities, experience and expertise. Our pharmacists and pharmacy technicians are devoted exclusively to compounding. They are supported by a team of customer care specialists, all certified through a state-approved examination. We employ state-of-the-art technology in every aspect of our operations in our 40,000 square-foot facility.
We take our role as healthcare providers and innovators as seriously as our clients do.
Dosage Forms
From creating placebos to compounding your Active Pharmaceutical Ingredients (APIs) into any number of dosage forms, through destruction and documentation of unused study materials, we offer a full complement of services to support virtually any research protocol. We prepare and deliver custom-compound APIs or placebos in these dosage forms: (More than 30 flavors also are available.)
|
Administration Method |
Dosage Forms |
|
Implant |
Beads and pellets |
|
Injection |
Solutions or suspensions (aqueous or oil-based) in vials, bottles, bags or single-dose syringes |
|
Nasal |
Sprays, solutions, drops, ointments, irrigations |
| Ophthalmic |
Solutions, suspensions, ointments, injectables |
|
Oral |
Tablets, including Gourmeds™ flavored chewable tablets and Tiny Tabs®; capsules, liquids, powders, pastes |
|
Otic |
Powders, otic solutions |
|
Rectal |
Suppositories, gels, enemas |
|
Topical/transdermal |
Solutions, creams, ointments, gels, Twist-a-Dose™ applicator |
Ask These Questions About Quality.
When so much is at stake, it’s important to choose a compounding pharmacy you can trust with your reputation. When you select a compounding pharmacy to partner with your research, be sure to ask questions like these.
We answer “yes” to every one:
- Are you committed to compliance with the USP <797> guidelines for sterile compounding? Have you completed a <797> gap analysis?
- Would you know if you are having a problem with your clean-room or aseptic-compounding environment? If you are compounding sterile preparations, do you conduct weekly lab-tests of air and surface samples in your clean room and other controlled environments?
- Is the air quality in your sterile compounding lab engineered for HEPA filtration to reduce particulates?
- Do you obtain independent, routine certifications of your clean rooms and laminar airflow hoods?
- Do you perform daily monitoring and documentation of your clean-room temperature and humidity?
- Is your staff properly trained and evaluated in aseptic manipulation skills, gowning technique and clean-room use?
- Do you filter (0.2 micron) in a Class 100 (ISO 5) laminar airflow hood contained in a Class 1000 (ISO 6) clean room, or autoclave where appropriate, to achieve sterility?
- Do you perform sterility testing according to USP <71> — Sterility Tests and USP <85> — Bacterial Endotoxin (Pyrogen) Test?
- Do you perform post-filtration filter-integrity testing?
- Do you have systems in place for handling complaints and investigating sterility failures and adverse events?
- Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers?
- Do you obtain Certificates of Analyses for all formula ingredients?
- Do you maintain both master formulas and lot-specific worksheets for all compounds?
- Can you immediately trace a prescription back to the original formula log-sheet and the source of ingredients?
- Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist?
- Do you verify the potency of finished compounds through weight, volume and yield checks?
- Do you perform pH testing on injections, ophthalmic preparations and other compounds?
- Do you perform HPLC verification on selected formulations?
- Does the pharmacy have adequate liability insurance?
- Are you active members of the American College of Apothecaries and the International Academy of Compounding Pharmacists?
Please accept our invitation.
We invite you to take a tour of our exceptional facilities and laboratories and to meet with our Clinical Trial and Investigational Research Support Team to discuss — and plan to provide for — your unique needs. Please telephone Melissa Buggy, research account specialist, at 856.832.1351 or Renee Lupo, R. Ph, F.A.C.A., F.A.C.V.P., technical-services pharmacist, at 856.832.1314 to arrange your visit.
1 Wedgewood Pharmacy is licensed and regulated as a pharmacy. We are committed to the strict requirements of Chapters <795> and <797> of the U.S. Pharmacopoeia for compounding non-sterile and sterile preparations. However, as a pharmacy creating custom-made medicines, we are not a manufacturer and are thus not required to be cGMP compliant. Clinical trials supporting new drug applications typically require that suppliers of APIs and placebos be cGMP compliant.