Han Consulting LLC
Pharmacovigilance Consultant | Medical Safety Strategist
Mission and Focus Areas
At Han Consulting LLC, my mission is to provide pharmacovigilance consulting services to pharmaceutical and biotech companies.
I offer expertise in Pharmacovigilance, Medical safety strategy, and Global regulatory submissions.
I am dedicated to helping my clients protect patients and achieve success in the competitive biotech industry.
Pharmacovigilance
I offer strategic consulting services as interim Head of PV to biotech startup companies looking to bring drug safety in-house in preparation for multiple Phase 2 / 3 clinical trials and/or NDA/MAA submission. Ability to oversee PV capabilities including SOPs, systems, vendors, governance, inspection readiness, individual and aggregate safety reports.
Medical Safety Assessment
I bring expertise in the evaluation of medical safety data from all sources, including non-clinical studies, clinical trials and literature, with a focus on summary submission documents (CTD M2.5, M2.7.4, EU-RMP).
Global Regulatory Submissions
I provide support for global regulatory submissions, including preparation and submission of CTAs, NDA/MAA, with associated rapid responses to queries.
Contact
Let's discuss how I can meet your company's needs with a free 30-min Introductory Consultation.