GMP Material for Drug Trials
Edge offers a cost-effective solution for obtaining GMP quality material as an alternative to traditional channels, such as contract manufacturers. As an FDA registered 503B Outsourcing facility, we are compliant with the following state, local, and federal regulations and guidelines:
- USP 795, USP 797, USP 800, USP 825
- Occupational Safety and Health Administration (OSHA);
- Food and Drug Administration (FDA);
- Good Manufacturing Practice (GMP) Guidelines.
Edge Pharma produces GMP material for clinical drug trials, including investigational product in complex dosages, concentrations, and schedules. With decades of expertise in both R&D and clinical pharmacy on staff, Edge is an ideal partner for sourcing GMP quality doses for Phase 1A, 1B, and Phase 2 drug trials. As an outsourcing Facility, Edge can move fast and remain cost effective for early Phase 1 and 2 trials.
Edge has experience with many drug trials including cancer research, new ophthalmology products, and allergy immunotherapy. A team of specialists is available to help you prepare an abbreviated new drug application (ANDA) for submission. All CGMP, quality, and business standards are met in the critical areas of clinical trial development and execution. Edge can custom compound medications with active and placebo dosage forms. These medications can also be provided in patient trial kits with pertinent information or other required documentation.
Edge provides the following benefits to both small and large scale IND clinical trials:
Located in Colchester, Vermont, Edge Pharma is equipped with a system that monitors environmental controls that exceeds international standards for temperature, humidity, and sterility. The Quality lab and QC team are an integral part of the process. A combination of state-of-the-art equipment, testing logs, and full-time staff scientists ensure that every batch of medication delivered is both correct and safe. Our manufacturing processes and quality control ensure product safety, integrity, and accountability.
Edge accommodates a wide range of batch sizes depending on the requirements of the study, including patient-specific dosing. We manufacture dosage forms in a variety of packaging options, and can accommodate complex dosing and storage protocols. Edge generates medications in various forms, including capsules, sterile injections, sterile preservative free eye drops, nasal sprays, transdermal creams and gels, topical sprays, suppositories, and sub-lingual drops.
Edge's rapid development process and streamlined production facility mean faster turnaround compared with traditional suppliers.
Even before undertaking a new project, a drug trial client will meet key team members within chemistry, microbiology, quality, pharmacy, and production. A dedicated project manager will provide a timely and proactive communication between parties, and the production team will ensure your clinical project stays on schedule and on budget.
Edge prides itself on being as transparent as possible with customers. As a drug trial client you will have full and constant access to department heads across the entire company, and throughout the entire process from contracting and R&D until receipt of finished doses.
Call or send us a message to discuss your needs in clinical drug trial. A member of our team will reach out to you shortly.