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.
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),
Nonclinical pre-feasibility evaluations
Preclinical and clinical development plans
Risk Evaluation and Mitigation Strategies (REMS)
Interested in learning more? Contact us for more information today.