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Agere Adds Regulatory Submission Support

Aims to expedite advancement through late stage trials

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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.

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