Overcoming Pitfalls and Challenges with Software Validation
As a quality consultant and quality system subject matter expert in the Life Sciences Industry…
CertaraJune 29, 2018
Apixaban for treatment of venous thromboembolism (VTEtx): Use of MBMA to support Phase 3 dose selection and beyond
Apixaban is an orally available, direct, selective inhibitor of the coagulation factor Xa that reversibly…
CertaraJune 2, 2018
Pharmacokinetic/ Toxicokinetic Services
As your partner for drug development and regulatory strategy, Certara has expanded its services to…
CertaraMay 18, 2018
What’s New in Enterprise 3.4 Q&A
Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded…
CertaraMay 17, 2018
Achieving Compliance with the FDA’s eCTD Mandate
The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance…
CertaraMay 4, 2018
