About Element Wilmington
Element Wilmington is an FDA-registered and DEA-licensed (schedules 2-5) laboratory specializing in clinical-scale, small-batch sterile fill-finish. With deep expertise in both large and small molecule therapies, Element Wilmington offers comprehensive support for a variety of finished dosage forms, including otic and ophthalmic aseptic fills, topicals, semi-solids, and non-aseptic liquid fills, potent compounds, controlled substances, and compounding pharmacy medications and drugs. Element Wilmington provides best-in-class stability programs and storage solutions, with 1,600 sq. ft. of walk-in stability chambers for 25C/60%RH, 30C/65%RH, and 40C/75%RH ICH stability studies.
Customers have an opportunity to view work being done in ISO Class 5/Class 7 aseptic core in close proximity, or from a remote location. Element Wilmington has a sterling reputation with local FDA and DEA district offices, as well as CDER, CBER, CDRH, CVM, OGD, FDA, and EMA.
Wilmington Featured Services
Aseptic Manufacturing & Sterile Fill-Finish
Element offers comprehensive sterile fill-finish solutions tailor-made to support clinical studies, compounding pharmacies and small-scale batches, including small bulk fills.
Parenteral Product Development and Phase I & II Clinical Manufacturing
Element is at the forefront of pharmaceutical development and manufacturing of parenteral formulations, providing specialist parenteral product development and clinical manufacturing services.
Topical Product Development and Clinical-Stage Manufacturing
Our topical drug development and clinical manufacturing services help you to formulate robust topical dosage forms, including gel, cream, lotion, ointment, suppository, and emulsion.
Pre-Clinical and GMP Clinical Trial Material Manufacturing
Element offers flexible, complete and seamless clinical-scale manufacturing support throughout the entire drug development life cycle, from pre-clinical manufacturing services to phase I and II clinical trial material manufacturing solutions.