Regulatory Affairs

  • Regulatory Affairs
  • Where you decide to conduct your early phase clinical trials could have a significant impact on your costs and timelines. There are lots of factors to consider when making that decision—in some cases, performing clinical trials in Canada and the U.S. simultaneously can be the right step towards optimizing your program. But as sure as maple syrup is great on pancakes, and mustard is better on hot dogs, some things are simply just a better fit.

    There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!

    You have questions; we have answers.

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    When you need quick answers to your burning questions, simply ask an Altascientist.   

    Chris McEvoy


    How does Altasciences expedite the process for acquiring CITES permits?  
    Watch the video »
    Connect with Chris »

    Scott Boley


    What are the advantages of selecting the miniature swine as a non-rodent model?
    Watch the video »
    Connect with Scott »

    Mathieu Saulnier


    Why is it important to have an in-house team dedicated to bioanalytical equipment?
    Watch the video »
    Connect with Mathieu »

    Lisa Sanford


    Do I need an IND before starting my FIH trial in Canada?
    Watch the video »
    Connect with Lisa »

    Roland Jbeily


    What should sponsors know about Canada’s regulatory requirements for CTA filings?
    Watch the video »
    Connect with Roland »

    Scott Boley


    What factors should sponsors consider when selecting a non-rodent alternative in their nonclinical studies?
    Watch the video »
    Connect with Scott »

    Ben Reed


    What do the recent expansions to Altasciences’ CDMO facility mean for current and future clients?
    Watch the video »
    Connect with Ben »

    Dennis DiBiagio


    How does Altasciences’ manufacturing site support the development of drugs that treat CNS disorders?
    Watch the video »
    Connect with Dennis »

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    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.
     

    Altasciences has been recognized as a 2023 CRO Leadership Award Champion in the Capabilities category, as voted by you in ISR’s annual CRO Quality Benchmarking survey.

      



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    Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines

    Altasciences' Proactive Drug Development Solution: Biologics

    We want novel therapies to be approved fast, while being safe for us. Regulatory agencies around the world strive to balance the critical elements of speed and safety; at the same time, a rigorous review process is a must. 

    Canadian research facilities are becoming a popular choice for American and European sponsors, carrying out hundreds of clinical trials each year.

    Best Practices for a Successful, Multi-Step Data Journey

    In this latest issue of The Altascientist, we guide you through the complex, multi-step data journey for Phase I clinical trials, from study conceptualization and protocol development, to data collection and analysis, through to final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.

    Speak with an expert to learn more about our service offering.

    Have a few more minutes? Check out these insightful resources:

    Quality is OUR Priority

    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 30th, 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.​​​​

    Medical Writing Expertise Is at the Heart of Your Submission

    Collaboration and communication means quality documentation for your drug development program. Our Medical Writing teams collaborate constantly with our experts and yours, ensuring that very scientific document required for your study is accurate, complete, and-compliant with regulatory guidance. From initial protocol to the final clinical study report, we deliver rapidly, without compromise.

    As a stand-alone solution, or part of an Altasciences study program, our Medical Writing team is ready to support you. You can work in unison with us on a Full-time equivalent (FTE)basis, or project by project, the choice is yours.

    Medical Writing

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