CNS Center of Excellence

Are you working on a CNS-active drug? With over 25 years of conducting preclinical and clinical studies, Altasciences’ CNS Center of Excellence experts have developed an extensive resource library, including webinars and scientific journals, to guide you through all phases of early drug development, from lead candidate selection to clinical proof of concept, and beyond.

Our Laboratory Sciences Compliance Group is focused on quality, as well as on delivering critical drug biomarker quantitation data throughout each drug development phase.

We provide you with:

• Regulated bioanalysis across a wide range of analytes, including small molecules, biologics, bioequivalence, bioavailability, drug to drug interaction studies, and oligonucleotides 
• Process audits and facility inspections
• Quality management systems
• RQAP-GLP Registered Auditors actively involved in the U.S. and Canadian regulatory communities (SQA, PRCSQA, CCSQA) 
• Risk assessment quality audit plans
• On-site inspections and study-specific audits
• In-house Regulatory Team to ensure trials are conducted per protocol and within ICH/GCP/CFR guidelines  
• Vendor qualifications
• SOP management
• GLP recognition-compliant archiving

You may also be interested in the following:

Join Dr. Kaylyn Koenig, on November 30^th, for a conversation about digital droplet PCR (ddPCR) in preclinical research, including how it compares to qPCR.
 

Register Now

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.​​​​

Avoid Roadblocks in CNS Drug Development

Development of drugs to treat central nervous system (CNS) disorders presents a unique set of challenges, including active pharmaceutical ingredients (APIs) with low solubility, poor bioavailability, or highly potent characteristics.

Altasciences is equipped to handle the formulation, as well as the preclinical, clinical, and commercial development of CNS drugs. Our FDA-registered and inspected cGMP manufacturing and analytical facilities are equipped with:

• DEA manufacturing and analytical license for drug Schedules I to V
• Segregated Grade C and D cleanrooms for the handling of highly potent APIs
• In-house R&D and formulation laboratories for drug product release and ICH stability testing
• Method development for low concentration formulations often used for psychedelics
• cGMP warehouse, including narcotic vaults and cold storage

Our scientific team has expertise with liquid-filled capsules, often the preferred dosage form for CNS drugs. We are also highly skilled in complex formulations and testing of controlled substances, including cannabidiols.

Get in touch to discuss how we can rapidly formulate and advance your CNS drug product to market.


Related Resources

• Webpage: Full Range of Manufacturing and Analytical Solutions
• Video: Handling of Highly Potent APIs and Controlled Substances 
• Webpage: An Integrated Solution for Your First-In-Human Trials 

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.

Discover Our R&D and Formulation Laboratories and Services

Analytical testing plays a pivotal role in all phases of pharmaceutical development. No matter how complex your molecule is, our scientists formulate it and use robust analytical instrumentation and processes to ensure the quality of your in-process or finished drug product, and rapidly advance it to the next phase of development.

Our analytical services include:

• Method development, qualification, and validation
• Drug product release testing
• On-site ICH stability storage and testing
• Controlled substance testing (DEA manufacturing and analytical license, Schedules I-V)
• Excipients and active pharmaceutical ingredients (APIs)
• Packaging components

Take a virtual tour of our R&D and formulation laboratories to see where the magic happens!

Want to benefit from our services? Book a consult today.

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.

The process from lead molecule identification to completion of a first‑in‑human trial can be long and complicated. But with Altasciences’ Proactive Drug Development solution, your timelines can be reduced by up to 40%. Your entire program will be managed by one organization and overseen by a single, cross-functional program manager to quickly and seamlessly advance your molecule from preclinical testing to first‑in‑human clinical trials, and beyond—helping you get your medicines to the people who need them, faster.

Learn more by downloading our eBook.