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OUR SERVICES


  1. Abuse Potential and Deterrence Related Services
  2. Early Stage Clinical Pharmacology and CNS Drug Development
  3. Scientific and Safety Advisory Boards
  4. Strategic Business Planning and Operations
  5. Support of Governmental and Public Health Policy Development
  6. Pharmacologic Expert Reports
  7. Study Placement

  1. Abuse Potential and Deterrence Related Services

    2. Our experience in this area is unmatched by any other providers. We have worked with more than 50  companies, conducted more than 100 human abuse liability studies, and have presented over 150 papers at international conferences. In addition we have helped our customers with meetings with the FDA, EMEA and SDA. Our extensive involvement in this field has resulted in us having a major impact on the Regulatory Guidelines in the field and gives us a unique insight into their interpretation.

    Specifically we can help you with:

    1. New Chemical Entities:
      • Regulatory strategic planning and risk management
      • Evaluation of pre-clinical data and placement of studies
      • Management of clinical TEAE during trials and discontinuation
      • Abuse liability study design, placement, project management, quality control, data analysis and interpretation, report preparation
      • Other human pharmacology studies
      • Scheduling assessment
      • FDA 8-Factor and EMEA preparation
      • Ensure FDA and EMEA compliance
      • Regulatory representation
    2. New Formulations for Abuse and Tamper Resistance:
      • Regulatory strategic planning and risk management
      • Planning of in vitro testing; placement of studies; evaluation of in vitro data
      • Human study design, project management, quality control, data analysis and interpretation, report preparation
      • Other human pharmacology studies
      • Labelling recommendations
      • Preparation of regulatory filings
      • FDA 8-Factor and EMEA preparation
      • Ensure FDA and EMEA compliance
      • Regulatory representation
    3. Professional Training and Education:

      4. Through our training and education program "Successful Regulatory Risk Management of Abuse Potential for New CNS Drugs, and Product Formulations", we offer individual and team workshops or seminars that are structured to your needs. The program can be as brief as a selected topic presentation to a full two day intensive training program.

      Available Modules and Topics include:

      1. Regulatory framework
      2. Pre-clinical studies
      3. Chemistry and manufacturing
      4. Abuse deterrence and tamper resistance
      5. Clinical adverse event management
      6. Human abuse liability study design
      7. Physical dependence and withdrawal
      8. Case studies
      9. Abuse liability assessment of tobacco products

  2. Early Stage Clinical Pharmacology and CNS Drug Developement

    3. Our experience includes:

    • Psychiatry (depression, anxiety disorders, Alzheimer's disease, alcohol and drug dependence, insomnia, cognitive impairment)
    • Neurology
    • Accelerate early stage studies with incorporation of biomarkers, disease models and patients in early studies
    • Study design, project management, data analysis and interpretation, report preparation
    • Access to specialty study sites

  3. Scientific and Safety Advisory Boards

    4. Our expertise in many aspects of basic and clinical psychopharmacology results in our participation in numerous advisory capacities. These include Boards and Committees related to international and national health and regulatory policy (e.g., WHO Expert Committee on Drug Dependence); public consultation (e.g., FDA Advisory Committees) and individual biopharmaceutical and device companies.

  4. Strategic Business Planning and Operations

    5. Companies engaged in biotech, biopharmaceutical and clinical study operations seek our advice on drug development planning;(re)structuring their business; financial planning and analysis; operations optimization; sourcing and negotiating private investor and venture capital financing; due diligence for acquisitions and licensing of biopharmaceutical and biotech IP and products; merger and acquisition opportunities; due diligence for Angel, Venture Capital and other investors; due diligence on potential licensing of psychopharmacologic agents; assessment of market opportunity in the addiction area.

  5. Support of Governmental and Public Health Policy Development

    6. One important goal of DL Global Partners is to contribute to advancing the regulatory science environment and to use our expertise and experience to support better informed public policy development and application.

  6. Pharmacologic Expert Reports

    7. Clients ask us to prepare, on their behalf, reports that cover a wide range of topics including: pharmacologic medico-legal evaluations; due diligence assessment of potential in-licensed products or business opportunities; critical reviews of topic areas.


  7. Study Placement

    8. Working on behalf of pharmaceutical and device companies we can help in study site screening and recommend placement of studies in North America, United Kingdom and Central and Eastern Europe. Specialty and patient study sites are increasingly important especially when they can apply advanced techniques and pharmacodynamics measurement for Proof of Mechanism and Concept studies. Dr. Romach is fluent in Ukrainian and has extensive experience in the Ukraine.