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    CSSS Services 

    Product Development
    Plan Assessment

    Identify a strategic pathway for the study and evaluation of a drug's abuse potential to support regulatory requirements and marketing approval

    Report Review and Interpretation

    Review nonclinical and clinical study reports, including interpretation of results, for controlled substances and drugs with abuse potential

    Preparation of NDA Submissions

    Prepare and review NDA submissions to support drug scheduling proposals related to abuse potential and dependence liability studies

    Schedule I Substance Studies 

    Prepare and advise on regulatory submissions related to conducting research on Schedule I substances

    Keep Up with New Advances

    Maintain currency with the Agency's public viewpoint and guidance to position clients' new products for successful outcome

    Protocol Design and
    Development
     

    Advise on the design and development of nonclinical

    and clinical protocols for the study of abuse potential and dependence liability, and abuse deterrence products

    IND Submission and Consultation

    Consult on Pre-IND submissions and regulatory meetings, INDs, and product development of drugs with abuse potential

    Product Study and Data Evaluation

    Collaborate with client's product development team to help manage study consistent with FDA guidelines and evaluate data

    Regulatory Outcome Advice

    Advise on possible regulatory outcomes for new drug products with abuse potential, including product labeling, drug scheduling, and the need for additional measures

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