Regulatory Affairs

  • Regulatory Affairs
  • Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes

    A Step-by-step Guide for Meeting Your Safety Assessment Start Dates

     

    Careful planning and financial commitment can make the difference between starting your safety testing studies on time or experiencing significant delays.

    Once you have determined your desired safety assessment start date, we recommend taking the following steps to ensure you start your studies on time, and on your terms.

    • 12-18 months before: 
      • Schedule a meeting with the FDA to go over your safety assessment plan.
    • 9-12 months before: 
      • Get quotations from your preferred CRO partners. 
      • After receiving the proposals, discuss your program with an expert toxicologist to ensure you captured all the required studies.
    • 6-12 months before (depending on research animal species and study type):
      • Choose a CRO partner and sign a contract. 

    Reach out to us today so we can go over these steps together and ensure your study starts on time.

    Are You Looking for Help with Scientific Publications?

     

    Scientific Publication Writing — Let Us Help!

    Altasciences’ scientific experts can provide you with strategic guidance and quality writing for your next scientific publication. Our solution includes writing for a wide range of therapeutic areas, for your preclinical to clinical research — as part of a full‑service program completed at our facilities or as a stand-alone offering.
     
    Benefit from: 

    • Strategic publication guidance and content development for manuscripts, posters, and abstracts
    • Expert review and editing of your pre-written publications
    • And more!

    Let’s get started!

    Have 5 minutes? You may be interested in:

    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.

    FDA and EMA Prefer Terminal Sterilization Over Aseptic Manufacturing ― Find Out Why

     

    Advantages of Terminal Sterilization Over Aseptic Manufacturing

    Regulatory agencies such as the FDA and EMA generally prefer terminal sterilization over aseptic manufacturing, as it provides a high level of sterility assurance. It is also less complex, less costly, more easily reproducible than aseptic manufacturing, and offers time savings to pharmaceutical companies.

    In this issue of The Altascientist, we discuss:

    • Differences between terminal sterilization and aseptic manufacturing 
    • Sterilization methods for pharmaceutical products
    • Validation steps during sterilization
    • Method selection 

    Read to learn how terminal sterilization can benefit your drug product. 

    Altascientist Issue 21

    Questions? Speak with one of our experts? Contact Us.

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    A History of Public Attitude Towards Psychedelic Drugs 

    Psychedelic drugs exist within a unique social, legal, and historical environment, with roots in the public imag

    Psychedelics — A New Era of Modern Medicine

     

    The potential use of psychedelics for the treatment of various CNS indications is filling the drug development pipeline. Researchers in the field are examining modified chemical structures and analogs to psychedelics, to demonstrate efficacy and mitigate potential side effects.

    In this podcast, Altasciences’ and DevelRx’s scientific experts examine the preclinical, clinical, and regulatory requirements and strategies that second-generation psychedelics may utilize to differentiate their pharmacological profile. We examine how to demonstrate efficacy and generate safety data that may distinguish psychedelics from first generation candidates. 

    Listen now

    The Next Trip

    Speak with an expert about your research needs.

    You may also be interested in the following:

    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.

    .custom-column-left-text { float: left; width: 50%; padding-right: 10px; } .custom-column-right-text { float: right; width: 45%; text-align:center; } @media only screen and (max-width: 600px) { .custom-column-left-text, .custom-column-right-text, .custom-column-flc-ebook-text { float:none; width:80%; margin:0 auto; } }

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

    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.

    You may also be interested in the following:

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    Your drug discovery phase is nearing completion and your funding is in place. What comes next?

    Navigating SEND with Altasciences

     

    If you are struggling with getting SEND data, Altasciences can help. Our personable and accessible SEND team is ready and able to answer your questions throughout your SEND process.

    As an active member of the CDISC SEND Consortium and Pharmaceutical User Software Exchange (PhUSE) nonclinical working groups, Altasciences contributes to the development of SEND standards and remains at the forefront of these evolving requirements.

    Contact a SEND expert today and start saving time.

    You may also be interested in the following:

    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.

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