We host an unrivaled spectrum of development capabilities that enable us to quickly determine a candidate's suitability, which in-turn shortens development time and significantly reduces cost.
Our catalog of in-house development capacity is extensive, and in addition we have access to further specialized equipment, including microscopes for crystallization detection, gas chromatography-mass spectrometry (GC/MS) equipment for impurity testing and HPLC/MS for impurity and unknown element detection.
With fast-screening to evaluate the potential of drug delivery combined with pilot-scale drying and nip equipment, plus a unique coater that mimics various larger-scale equipment, speed and quality go hand in hand.
Our in-house human-wear studies, purity and impurity profile development methods, and physical testing following FDA guidelines compliment our skin permeation and flux studies using human skin.
Using the Gold Standard of human skin permeation we can quickly predict the outcome of our in-vitro test to in-vivo outcomes, offering assurance that every step, of every process, is delivered with the utmost confidence.
Our manufacturing arm, Greene Street Manufacturing solely produces Greene Street Pharmaceutical formulated products for licensees.
We do not act as a CMO, however, we possess comprehensive in-house facilities giving us the capability to produce all of the portfolio products developed by Greene Street Pharmaceuticals.
With established, global, dependable API sourcing relationships spanning as wide as Europe, China, and India, each of which is FDA approved, we are well placed to commence and scale production to meet project requirements.
Our specialized infrastructure for development, piloting, and manufacture includes commercial coaters, semi-auto packaging machines, computer-driven die cutters, Industrial rollers, roll mixers, and agitated small tank mixers.
Our FDA registered facility and the successful completion of multiple audits confirms our ability to produce under cGMP standards. With a mock PAI scheduled to obtain full FDA and EMA approval, we're well positioned to manufacture at scale.
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