Regulatory Solutions

  1. 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).

  2. Advarra Regulatory Consulting 6/10/2021

    Our regulatory consultants take action and move your research forward. If you’re looking for help in the development of innovative life science and digital health products, then Advarra® is the answer.

  3. Regulatory Affairs Consulting 4/28/2021

    Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.

  4. 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.

  5. 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.

  6. Global Pharmacovigilance And Safety Solutions 4/23/2013

    As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.

  7. 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.

  8. 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.

  9. DIA NOW In Focus 1/28/2020

    Learn more about DIA NOW In Focus on Pharmacovigilance, the scope of the content offered, and how it can help you keep current and gain insights into hottest Pharmacovigilance topics from around the world.

  10. 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.