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
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Data quality appraisals for safety and efficacy
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Reviewing documents for sufficiency of the supportive evidence
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Assessments of pre-submission and scientific data gaps
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Interpretations of data science and clinical reports
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Medical writing and providing insights
Regulatory Science Submissions
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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
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Nonclinical pre-feasibility evaluations
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Preclinical and clinical development plans
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Risk Evaluation and Mitigation Strategies (REMS)
CONTACT US
Interested in learning more? Contact us for more information today.
EMAIL:
PHONE:
+1 240-242-7471