Advanced Pharma Consulting LLC specializes in integrating 30 years of pharmaceutical manufacturing experience to assist you in achieving and sustaining your technical and compliance goals.
Experience in multiple physical manufacturing processes enables comprehensive assessments, roadmap options, readiness exercises and mockup audits to help you drive success.
Extensive successful experience with US and OUS inspections includes FDA, EMA, ANVISA, PMDA, DEA among other key regulatory agencies.
Wanda Hernandez
Hernandez is a pharmaceutical manufacturing, quality and product development professional with 30 years of industry experience in multiple leadership roles. She has strong experience in oral and injectable manufacturing technologies, general inspections, drug product submissions, and pre-approval inspections. She successfully collaborated and managed in cross-cultural and cross-functional environments including external organizations. Hernandez has a B.S. in Pharmaceutical Sciences from the University of Puerto Rico-School of Pharmacy.
Some key accomplishments
Technical and quality leadership in drug product development and process transfers in US, Puerto Rico, France, United Kingdom, Brazil and Mexico.
Technical and quality oversight and support for manufacturing processes including successful implementation of multiple facilities, equipment, product processes, and quality projects/agendas.
Technical and quality oversight and support for regulatory documents, pre-approval inspections, and readiness activities for over fifteen successful drug product applications.
Internal and external collaborations to establish alignment of technical and quality standard practices.
Advanced Pharma Consulting, LLC
Carmel, IN
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