An Overview of Health Canada's CTA Process
Watch this podcast in which Altasciences' regulatory experts share key insights on Health Canada's Clinical Trial Application (CTA) regulatory submission process, including answers to your most common questions.
Altasciences’ Canadian clinical facility consists of seven Phase I units. We conduct over 100 trials every year in Canada, and support the full range of first-in-human studies, specialty studies, and therapeutic areas, such as ophthalmology, CNS, and substance abuse.
Take five minutes to explore these insightful resources:
Rapid High-Precision Flow Cytometry Solutions
Customized Panels for Optimal Results
Experience Altasciences’ exceptional flow cytometry services!
We provide accurate cell counting, biomarker detection, and innovative protein engineering for your nonclinical and clinical studies.
With our expertise in exploratory and GLP studies, we offer tailored panels for immunophenotyping and cellular activation. In addition, our labs in the U.S. and Canada are near our clinical pharmacology units, ensuring seamless transitions and swift sample analysis.
Speak with one of our flow cytometry experts.
See our related webpages below:
Purpose-Built Facilities for Cell and Gene Therapies
Advanced Early Phase Development Solutions
Altasciences has a purpose-built facility focused on exploratory and early development research in nonhuman primates (NHPs). Our Sacramento (CA) site, in particular, is dedicated to developing cell and gene therapies, such as adeno-associated virus (AAV) or lentivirus (lenti) products, and applying gene editing technologies like CRISPR/cas9.
Discover the Altasciences difference:
• Extensive in-house capabilities and experience (including historical background data)
• Operational experience with infant/juvenile NHPs for long-term studies
• Surgery expertise for biopsies, such as in gene editing studies requiring repeated liver sampling
• Special necropsy procedures to avoid contamination and ensure the integrity of genomic material in tissues
• GLP laboratory in Seattle (WA) to perform qPCR/RT-qPCR of vector and biodistribution and persistence of vector/transgene in tissues
Consult with one of our experts to discuss your study needs.
SUBMIT AN INQUIRY
Related resources that may interest you:
• Webpage: Full Range of Preclinical Drug Development Solutions
• Fact Sheet: Preclinical Services Capabilities
• The Altascientist: Planning Your Preclinical Assessment
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.
Cutting-Edge Bioanalytical Platforms for Unparalleled Data Accuracy
The Key to Reliable Results
Choosing the right bioanalytical platform, best suited for your study or program, is crucial for accurate, reliable, and quality data.
Altasciences can determine the ideal option for your specific assay needs, and offers a diverse range of cutting-edge bioanalytical platforms and capabilities, including:
- 30+ mass spectrometry systems
- automated workflows for large molecule extraction
- high-throughput automation
- multiplexing options, and reliable handlers and homogenizers
- absorbance/fluorescence/luminescence assays
Speak with one of our bioanalytical experts to find out which platform is most appropriate for your specific drug development project.
You may also be interested in these webpages:
Accelerating Global Drug Development Timelines With Ethnobridging
Safe Strategy to Save Time and Money
Avoid repeating Phase I studies for drugs intended for the Asian market. Altasciences has the clinical capabilities to demonstrate the biosimilarity of drug products between Asian and non-Asian populations by comparing the pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money.
Key resources for ethnobridging in Phase I clinical trials:
In this issue of The Altascientist, we demonstrate how ethnobridging can prevent the need for region-specific development programs, helping you safely achieve commercial milestones more efficiently. Download your copy today.
In this complimentary webinar, Mel B. Affrime, PharmD, Executive Vice President, Translational Medicine, discusses how ethnic differences can impact the bioavailability of your drug candidate and how to design a multiregional clinical development program to hasten worldwide regulatory approval safely. Watch the webinar.
Speak with an expert today to discuss your next clinical program.
You may also be interested in the following webpages:
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.
A Game-Changer for Poorly Soluble APIs
A Game-Changer for Poorly Soluble APIs
Fact: Over 70% of active pharmaceutical ingredients (APIs) entering the drug development pipeline are poorly water-soluble and thus, insufficiently bioavailable.
Nanomilling is one of the most effective proven techniques used to resolve solubility challenges and can be applied to almost any API with water solubility below 200 μg/mL. Benefits include particle size reduction, ease of scalability, reduced fed/fasted variability in both liquid and solid dosage forms, faster onset of therapeutic action, and low excipient side effects.
Learn more about our extensive expertise in nanomilling with a broad range of APIs, or speak with one of our formulation experts to find out how we can help.
Related resources that may interest you:
• Webpage: Global CDMO for Drug Manufacturing and Analytical Testing Services
• Scientific Journal: Nanomilling for Better Solubility and Enhanced Bioavailbility
• Webinar: The Development of Nanosuspension Formulations
Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines
Selecting the Right Pain Model for Your Study
Experience You Can Count On
With over 25 years of experience, Altasciences offers pain stimulation models and pharmacodynamics tests for early phase analgesic trials. These tests provide critical data for informed decision-making. Our team of pain experts and neuroscientists is here to assist you in selecting the most appropriate pain model to successfully evaluate your study drug's efficacy and safety profile.
Discover how we can deliver the solutions needed for your pain research.
You may also be interested in the following resources:
• Webinar: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
• Pain Model Poster: Inside the Pharmacodynamic Toolbox
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.
Scratching the Surface of Nonclinical Dermal Testing
Altasciences Simplifies Dermal Safety Testing for You
To bring your molecule from discovery to clinical proof-of-concept and beyond, Altasciences' team of toxicologists and technicians provides a wide range of dermal services. We work with you to develop new or validate existing dermal models, and perform GLP and non-GLP toxicology studies to support both 505(b)(2) and new chemical entity regulatory filings.
When you partner with Altasciences, you benefit from a CRO who can:
• Conduct safety assessments on both small and large molecules
• Design and conduct standard and specialty dermal toxicology studies that support your FDA filings
• Assess topical therapies using miniature swine and nonhuman primates
View our eBook on the topic, or consult with one of our experts to discuss your study needs.
You may also be interested in these related resources:
• Webpage: Full Range of Preclinical Drug Development Solutions
• Fact Sheet: Preclinical Services Capabilities
• The Altascientist: Planning Your Preclinical Assessment
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.