Psygen specializes in API development for psychedelics and neuroplastogens, including process R&D and phase-appropriate small molecule API manufacturing.
Psygen’s team of expert psychedelic chemists, provide targeted synthetic expertise. Our quality team carries expertise in analytical method development and validation for psychedelics and neuroplastogens. By closely collaborating with our clients, we ensure responsive and adaptable manufacturing tailored to your project’s unique requirements.
Our integrated CMC services are designed to produce high-quality APIs, facilitating a smooth transition from process development to clinical manufacture and ultimately scaled commercial production.
Our R&D lab excels in designing efficient and scalable pathways for small molecule API production, ensuring consistent and reproducible quality. With proven expertise in psychedelic and neuroplastogen chemistry, and analytical method development, we deliver phase-appropriate studies tailored to the project.
In the early stages, we utilize process development tools, such as Design of Experiments (DoE), to optimize reaction conditions, and to establish Critical Process Parameters and their relationship to Critical Quality Attributes. This meticulous groundwork establishes a robust foundation for subsequent phases of production, where we refine specifications and optimize reaction parameters to ensure the highest quality, every time.
Our Phase I-III small molecule API development and manufacturing services ensure a seamless transition of APIs from process development to GMP manufacture. We are focused on phase-appropriate development tailored to your project’s unique needs.
With extensive experience in psychedelic drug substance manufacturing, our skilled chemists work closely with you to establish the most critical pathway to success, optimizing supply, minimizing risk, and expediting time-to-clinic.
Is your current manufacturing solution insufficient? Do they lack the capacity, the expertise or the flexibility you require?
Psygen is capable of handling tech transfers for clinical or commercial API manufacture.
