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Following decades of stagnation, the field of psychedelic research is being revitalized by the investigation of their potential benefit for mainstream psychiat

We’re Committed to the 3Rs

 

Through our commitment to the 3Rs and our careful adherence to regulatory guidelines, we maintain an unwavering focus on the welfare of the laboratory animals in our care.

In this podcast series, Dr. Christina Cruzen, Altasciences’ Attending Veterinarian and Chief Animal Welfare Officer, discusses our dedication to the 3Rs.

  • Episode #1: The recent advancements made to Altasciences’ 3Rs program.
  • Episode #2: Interview with Dr. Megan R. LaFollette, Program Manager at The North American 3Rs of Animals in Research Collaborative (NA3RsC), on the importance of animal welfare, how the role of animal research is changing, and much more.

Speak with Dr. Cruzen to discover how we make animal welfare a constant priority.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

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Video:

Webpage: Preclinical Services

How Is Partnering with Altasciences for Your First-in-Human Clinical Trials Different?

Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone in your drug development program. Altasciences is here to help you get there, conduct your study, and provide you with a full range of complementary services.  

A Different Kind of CRO

Altasciences offers a unique integrated approach that can reduce program timelines by as much as 40%, lowering costs and getting better drugs to the people who need them, faster.

  • Regulatory expertise
    o   Our regulatory advisors have extensive experience navigating complex regulatory processes, ensuring your IND and CTA applications are submitted and processed swiftly and efficiently.
  • Scientific and operational expertise
    o   You can trust our team to deliver high-quality, customized solutions for your clinical trial needs.   
  • Pharmaceutical manufacturing
    o   We offer a wide range of manufacturing services to support your preclinical and clinical trials.
  • Bioanalysis
    o   With over 200 highly trained specialists and a capacity of over 60K study samples per month, Altasciences has the capacity to process your data quickly.
  • Project management

 

 

 

 

A single, dedicated project manager, along with a proprietary information-sharing database, means you only have to Tell Us OnceTM. Learn more about Altasciences’ FIH solutions.

 

Speak with one of our experts.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

Method for Surgical Closing of Muscle Biopsy Sites on Nonhuman Primates in Group Housing

Let’s Talk Integrated Clinical and CDMO Solutions

 

Quality and Excellence with Integrated Clinical and CDMO Solutions

Shawn Connaghan, Executive Vice President of Administration and Quality Management, Manufacturing, discusses how Altasciences’ integrated manufacturing and clinical solutions can benefit your drug development program. 

Topics covered:

  • Advantages of integrated manufacturing and clinical solutions
  • Quick project start-up
  • Maintaining high-quality standards
  • Adapting to sponsors’ unique needs

WATCH NOW

Quick Chat with Shawn Connaghan, Executive Vice President of Administration and Quality Management

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

How Nano Milling Saved Our Client’s Poorly Soluble Compound

 

Case Study: Nano Milling from Screening to Scale-Up

Have you ever had a challenging API with poor water solubility and bioavailability, and didn’t know how to improve the formulation? Our client did, and they came to us for help!

Download our case study to learn how Altasciences determined the suitability of nano milling to increase the drug’s dissolution rate and bioavailability, making sure our client had it ready on time for their first-in-human clinical trial.

READ CASE STUDY

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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. 
 

Expert Support for Your IND/CTA Requirements

Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.

Contact our experts today.

Altasciences can help you compile the key information necessary to approve your application request, including:

  • Animal pharmacology and toxicology studies to assess safety
  • Manufacturing processes to ensure consistent batches of the study drug
  • Clinical protocols and investigator information to assess tolerance and risk

For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.

Altasciences’ Proactive Drug Development platform transforms the traditional outsourcing paradigm by providing you with expertly designed, customized roadmaps that seamlessly bring you from lead candidate selection to clinical proof of concept, and beyond.

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Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay

Mitigation of On-Column Conversion of Ivabradine to Desmethylivabradine Metal Chelation With Citric Acid Modifier

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