Document Quality and Management Page
Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.
Strategic Evidence & Value Communication Symposium On-Demand Webinar
Join us on Wednesday, April 21, 2021, from12:00 PM – 2:00 PM EDT for Certara's first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.
Legislators: Bring all stakeholders to the table to lower drug costs Press Coverage
BY ROMAN CASCIANO, OPINION CONTRIBUTOR — 03/29/21 05:30 PM EDT No one is happy with the price of drugs nor how we pay for them: not patients, not the lawmakers who represent them, not physicians, not insurance payers and not drug...
Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure On-Demand Webinar
The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. ...
Getting started with in-house development: how does it work? Blog Post
Learn how in-house app development with BaseCase enables rapid creation, centralized management, and unmatched flexibility to communicate product value.
Getting started with in-house development: storyboarding Blog Post
Learn key storyboarding best practices to optimize your in-house mobile app development & effectively communicate product value.
Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation in the United States Publication
Authors: Joseph McGuirk, Clint Divine, Seung Hyun Moon, Aastha Chandak, Zhiji Zhang, Genovefa A. Papanicolaou Hemorrhagic cystitis (HC) caused by viral infections such as BK virus, cytomegalovirus, and/or adenovirus after allogeneic hematopoietic stem cell transplantation (allo-HCT) causes morbidity and mortality,...
Health Canada PRCI Guiding Principles and Observations Blog Post
Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for...
Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development White Paper
Do expensive bioequivalence studies stall your generic drug approval? Learn how you can streamline complex generic drug development with our white paper.
