DSI - DS InPharmatics
Bettina Kaplan has extensive work experience in quality assurance and compliance roles in the pharmaceutical industry. Bettina currently serves as the Head of Quality Assurance Services at DSI - Design Space InPharmatics LLC, a position they have held since February 2021. Prior to this role, they worked as a Senior Quality Assurance Consultant at the same company from December 2016 to February 2021.
Before joining DSI, Bettina worked as a Quality & Compliance Consultant for the Pharmaceutical Industry at BKK Consulting, LLC starting in November 2013.
Bettina also held the position of VP, Quality & Compliance at Monosol Rx, LLC from March 2013 to November 2013.
From October 2009 to December 2012, Bettina served as the Head of Quality and Compliance at Sandoz Pharmaceuticals, where they were responsible for development in the United States.
Earlier in their career, Bettina held various positions including Director of Quality and Compliance at Elite Pharmaceuticals from April 2008 to October 2009, Owner of BKK Consulting, LLC from July 2007 to October 2009, and Director of SQA at Purdue Pharma from September 2004 to July 2007.
Bettina began their career as a Manager of QA at Thompson Medical Company, where they worked from November 1986 to October 1999. Throughout their career, they have demonstrated expertise in managing government agency inspections, coordinating PAI teams, performing QA audits of suppliers, and overseeing QA and QC operations.
Bettina Kaplan obtained a Bachelor of Science (BS) degree in Chemistry from Stevens Institute of Technology during the period from 1975 to 1979.
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DSI - DS InPharmatics
DS InPharmatics (DSI) offers one-stop, full-service CMC consulting resources to emerging pharmaceutical and biopharmaceutical companies. The exceptional value DS InPharmatics offers begins with our dedicated, multidisciplinary teams of manufacturing, quality, and regulatory affairs specialists. Our CMC consultants combine in-depth technical knowledge of product development with risk-based submission content and regulatory strategies for all phases of the review and approval process. This breadth of pharmaceutical development expertise provides you with a single, integrated source for efficient problem-solving strategies and scientific expertise. Whether your needs are comprehensive or tightly focused on a specific project, our experienced CMC consultants will help keep your drug development program on track. Not just advice. DSI provides you with hands-on, flexible resources and expanded operational capability, to implement a compliant drug development strategy and timelines. In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group. Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database – as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements. We see enormous potential in this new chapter for DSI and for you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we’re incredibly excited to add our momentum to that effort.