Overcoming Challenges in the Formulation and Development of Controlled Substances

 

Partnering for the Development of Psychedelics, Cannabidiol (CBD), and Other Scheduled Drugs

Altasciences can help develop and commercialize first- and second-generation novel therapeutics for the treatment of mental health, addiction, and CNS disorders. We are a recognized CNS center of excellence, specializing in the formulation, development, analysis, testing, and manufacturing of controlled substances for clinical trial supply all the way through to commercialization.

When partnering with us, you benefit from our state-of-the-art facilities and advanced expertise, including:

• DEA license for drug Schedules I-V for manufacturing and analytical services
• FDA-registered and inspected facilities, including cGMP manufacturing suites, segregated Grade C/D clean rooms, warehouses, and cold storage 
• cGMP-compliant analytical laboratory for drug product release and ICH stability testing
• Expertise with small molecule APIs, simple and complex formulations of highly potent compounds, and controlled substances
• Experience with formulation development and optimization of cannabinoids
• Experience developing methods for low concentration formulations often used for psychedelics
• Experience with all aspects of drug product characterization
• Clinical supply and commercial manufacturing, packaging, and shipping
• Regulatory and technical guidance and support 

Get in touch with our experts today to discuss your project’s needs.

Got a few more minutes? You may also be interested in the following:

• Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
• Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry
• E-Book: The Benefits of Liquid-Filled Capsules in Pharmaceutical Development

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.