Ask Me Anything: Career Opportunities in Regulatory & Medical Writing

Have you ever wondered what it would be like to be a Regulatory or Medical Writer in the pharmaceutical industry? Certara’s global regulatory writing team includes PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory). Our team is growing, and we’re looking for people with … Continued

Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator

Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform drug labels. Thus, regulatory agencies are recommending more rigorous demonstration of the prediction accuracy of PBPK platforms in their intended use.  During this webinar, we present a framework for qualification of the Simcyp Simulator … Continued

Certara Reports First Quarter 2022 Financial Results

PRINCETON, N.J.—May 5, 2022– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2022. First Quarter Highlights: Revenue was $81.6 million, compared to $66.7 million in the first quarter of 2021, representing growth of 22% over the first quarter of 2021. Excluding Pinnacle … Continued

Certara to Participate in Upcoming Investor Conferences

PRINCETON, N.J.— May 3, 2022 — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in the following investor conferences: Bank of America 2022 Healthcare ConferenceDate and Time: Tuesday, May 10 at 3:00 p.m. ET Citi’s Biopharma Virtual Co-Panel DayDate and Time: Wednesday, May 18 at 10:00 a.m. … Continued

Certara Wins 2022 Edison Award for COVID-19 Vaccine Model

PRINCETON, N.J., May 3, 2022 — Certara, Inc., a global leader in biosimulation, today announced that the Company’s Simcyp COVID-19 Vaccine Model has been awarded a 2022 Bronze Edison Award in the Therapeutic Impact category. The Simcyp COVID-19 Vaccine Model, which is incorporated in Certara’s Vaccine Simulator, uses biosimulation and computer-generated, virtual populations to facilitate … Continued

Simulating Realistic Virtual Bioequivalence using Simcyp Simulator: Estimating Within-subject Patient Variability

While using physiologically-based pharmacokinetic modeling (PBPK) in determining virtual bioequivalence (VBE) has significantly increased over the past few years, this type of mechanistic biosimulation still offers enormous potential to supplant expensive and time-consuming clinical studies. The paper referenced below addresses our increased knowledge of oral drug absorption and the applicability of the Simcyp Simulator to … Continued

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