Breaking News

Agere Adds Regulatory Submission Support

December 4, 2012

Aims to expedite advancement through late stage trials

Agere Pharmaceuticals has added Regulatory Guidance to its portfolio of services. The company now supports clients in navigating, organizing and submitting regulatory documents to the FDA and other regulatory agencies. Part of the new offering includes electronic regulatory submissions to the FDA through the Electronic Submission Gateway (ESG).
 
“Outsourcing R&D as well as preclinical development has been a growing practice for years,” said Vince Foley, director of Quality for Agere. “It makes sense for an Agere client to benefit from our expertise in regulatory guidance to expedite getting their drug to the clinic and to advance through later stage clinical trials.”
 
Agere management and scientists offer extensive experience in regulatory submissions including ESG, eCTD (electronic Common Technical Document), IMPD (Investigational Medicinal Products Dossier), IND (Investigational New Drug), and Drug Master File (DMF), as well as knowledge of ICH (International Conference on Harmonization) guidelines.

blog comments powered by Disqus
  • Newsmakers: PCI

    Newsmakers: PCI

    Tim Wright, Editor||June 2, 2015
    PCI execs talk about the recent opening of the company’s new North American clinical facility, as well as other trends in the market

  • How Sterilization of Primary Packaging Influences the Results of E&L Studies

    How Sterilization of Primary Packaging Influences the Results of E&L Studies

    Thorsten Sogding, Daniel Canton, Daniel Haines, Uwe Rothhaar, SCHOTT Pharma Services ||June 2, 2015
    As the demands that are being placed on the quality and stability of medications continue to increase, the interactions that take place between the primary packaging container and filled drug product are becoming increasingly important

  • Moore’s Law for More Health

    Moore’s Law for More Health

    Patrick Jordan , Encore Health Resources||June 2, 2015
    This year marks the semicentennial anniversary of a prediction about exponential growth and productivity