Regulatory Solutions

  1. PhlexSubmission 2/19/2021

    PhlexSubmission is a robust, highly configurable and easy-to-use publishing engine for electronic submissions such as eCTD, NeeS VNeeS but also it can provide paper publishing capabilities for CTD and any custom type submissions that might be required.

  2. PhlexIDMP 2/19/2021

    Start managing your IDMP data with Phlexglobal today! PhlexIDMP is a single regulatory database that will help you to avoid redundant data  that exists within your submissions. PhlexIDMP is based on two key components - controlled vocabulary management and codes - that deliver the best ready to use IDMP management solution.

  3. Electronic Trial Master Files 4/23/2013

    As life sciences companies move to semi-virtual environments keeping only the most vital functions in house, more and more Trial Master Files are being converted to an eTMF format.

  4. Marketing Applications For Regulatory Approval 4/23/2021

    Preparing regulatory marketing applications to their successful conclusions is our focus.

  5. Pharmacovigilance System Master File 4/23/2013

    One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.

  6. Institutional Biosafety Committee (IBC) Reviews 3/30/2021

    IBC review involves the deliberate transfer of engineered genetic materials to human research subjects. Read our latest brochure on IBC review.

  7. Ten Big Questions To Ask Your Clinical Transparency Solution Partner 10/3/2018

    When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.

  8. PhlexRIM 2/19/2021

    Comprehensive Phlexglobal Regulatory Information Management (PhlexRIM) will help the life sciences organizations effectively and efficiently drive the development, capture, dissemination, control and management of regulatory focused information throughout the product lifecycle.

  9. TrialScope Global Disclosure Compliance Overview 11/4/2020

    Global clinical trial disclosure poses a challenge for many sponsors due to disparate tracking tools, teams located around the world and constantly changing regulations. However, sponsors can reduce risk with real-time access, metrics and answers.

  10. GxP Auditing, Compliance, & Specialized Consulting Capabilities & Services 2/18/2020

    Site audits, vendor qualifications, GxP consulting, and so much more. Advarra’s experts can work directly with your team to provide global consulting and evaluation services related to research (including GCP, GLP, GMP, and GVP), clinical quality assurance (CQA), regulatory compliance, and human research protection (HRP).