Heidi N.

Vice President, Drug Discovery and Development at CSSI LifeSciences

Role: Vice President, Drug Discovery and Development at Qnova Lifesciences
Location: Painesville, OH, US
LinkedIn followers: 500 followers

Research & DevelopmentView LinkedIn profile

About Heidi N.

Experienced professional with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Vaccines, Biologics, Clinical Trials, Biotechnology, U.S. Food and Drug Administration (FDA), and Life Sciences. Strong research professional with a PhD focused in Molecular and Cell Biology from University of Wisconsin-Madison.

Experience

Vice President, Drug Discovery and Development
Qnova Lifesciences
Sep 2020 — Present

Education

University of Wisconsin-Madison
PhD, Molecular and Cell Biology
1986 — 1993
Duke University
BS, Biology, Russian
1981 — 1985

Contact information

Verified work emails, personal emails, and direct dials — unlocked in one click.

Work email
•••••@cssilifesciences.com
Personal email
•••••@•••••.com
Direct dial
+•• ••• ••• ••••

Unlock verified contacts

Free to start · No credit card required

Current company

Qnova Lifesciences

Pharmaceutical Manufacturing · 8 employees · Columbia, Maryland, United States

QNova LifeSciences Drug & Medical Device Commercialization & Medical Device CRO Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. Unparalleled Success from Discovery to Commercialization • Commercialized over 500 new drugs, biologics, medical devices, and in-vitro diagnostics • Over 250 medical device 510(k) Class 1-3 submissions with 100% success. • Extensive Orphan, “First in Class,” and “First In” Indication success. • Reduced time to approval by over 600 days. • Over 100 NDA, ANDA and BLA submissions, with 96% success. • Greater than 60 EMA CHMP Marketing Authorizations. • SmartStudyTM design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%. QNova LifeSciences Medical Device CRO has experience navigating regulations in over 100 countries. Often companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e, Class 1-3), specific product claims, and intended use. Our diverse team has many years of medical device commercialization experience, with the knowledge that goes beyond published guidance, documents and initiatives. QNova LifeSciences Medical Device CRO aims to impact the timeline of regulatory clearance and increase profitability.

cssilifesciences.com

Find verified contacts for anyone on LinkedIn

Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.

Start for free See how it works

Free plan included · No credit card required

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

About Heidi N.

Experience

Vice President, Drug Discovery and Development

Education

University of Wisconsin-Madison

Duke University

Find verified contacts for anyone on LinkedIn