EXPERIENCE NOVOMED CONSULTING

 
ABOUT NOVOMED CONSULTING

Founder Reza Sadaie, Ph.D. has broad knowledge and experience in regulatory sciences and product development, and served as consultant at the US-Food and Drug Administration, NIH, academia, industry and research institutes.  Dr. Sadaie has numerous publications and lectured internationally.

 
OUR SERVICES

NovoMed Consulting offers a variety of healthcare consulting services to assist in getting a new drug or biologic to market as well as other specialized services to assist pharmaceutical and biotech companies. Our experts have hands-on regulatory and FDA experience to guide you through this multi-faceted process.

Document Review

  • Data quality appraisals for safety and efficacy 

  • Reviewing documents for sufficiency of the supportive evidence

  • Assessments of pre-submission and scientific data gaps

  • Interpretations of data science and clinical reports

  • Medical writing and providing insights 

Regulatory Science Submissions

  • Data mining, monitoring, and drafting publications and clinical reports
    for “previous human experience”  and pharmacovigilance studies

  • Compilation, summation and tabulation of supportive evidence for timely reports and regulatory submissions: 
    Orphan Drug Applications  (ODA), Investigational New Drugs (Pre-IND, IND), post-marketing approval (PMA),

Safety Evaluations

  • Nonclinical pre-feasibility evaluations

  • Preclinical and clinical development plans

  • Risk Evaluation and Mitigation Strategies (REMS)

 
CONTACT US

Interested in learning more?  Contact us for more information today.

EMAIL:

PHONE:

+1 240-242-7471

 
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