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About MD to MD Consulting

The MD to MD Consulting, LLC provides various services to assist global small/mid-size pharmaceutical/biotech companies in building or transforming PV/drug safety functions with a focus on patients' safety via proactive and streamlined safety surveillance as well as efficient and time/cost-effective solutions in the quest for bringing more novel treatment options to the patients. • Strategic and practical input pertaining to all aspects of drug safety and pharmacovigilance activities in all stages of clinical development (Phase I-IV) and post-marketing safety surveillance, signal detection, benefit/risk evaluation and risk management activities. • Medical oversight of individual patient safety (medical review of ICSRs or acting as a Medical Monitor) and aggregate safety data to ensure proactive and timely benefit-risk assessment and risk mitigation. • Input for safety sections of regulatory documents including protocols, IB, RSI, ICF, CSR, CCSI, DSUR, PSUR, BLA, IND, NDA, sNDA, USPI, SmPC, health authorities/regulatory query responses, etc. • Strong knowledge of current signal management and visualization tools and hands-on experience building safety dashboards (AEs, SAEs, Labs, etc.,) enabling safety teams to have immediate access to the aggregate safety data and perform exploratory analyses. • Hands-on experience in building and managing safety teams; hiring and training physicians transitioning from medical practice to industry; developing and implementing outsourcing plans, vendor oversight activities to ensure high quality of the outsourced deliverables. • Develop and implement heath hazard evaluation and product complaint reconciliation activities; support inspection readiness and provide expertise in audits, inspections and CAPAs; SOPs/WIs creating and updates.

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