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Key regulatory trends laying the foundation for updated policies, risk-based regulatory frameworks, and forward-looking initiatives.
By: David Cameron
Will provide planning, coordination, and execution of all tasks relating to the development, and maintenance of regulatory documents.
By: Anthony Vecchione
FDA expects the new system to advance OPQ’s focus on pharmaceutical quality, the foundation for ensuring the safety and efficacy of drugs.
By: Sharif Ahmed
A review of FDA expectations
By: Jean Poulos
A closer look at electronic submissions of manufacturing establishment information (MEI).
Comprehend Launches Clinical Intelligence Suite, Quintiles Launches CGM Service Offering, and more...
By: Kristin Brooks
Ronald Hernando of MacroGenics discusses his journey to the cloud at DIA’s RSIDM Forum in Bethesda, MD, February 8-10.
New business models and analytics are driving increased value and efficiency in CRO-sponsor partnerships
Gains two OTC women’s health products
Topical PE treatment looking for OTC approval
By: Gil Roth
Ablynx, Alvine, Boehringer, Charleston, Innovus, Lumena, Merck, PharmaLink
Aims to expedite advancement through late stage trials
By: Tim Wright
Schmidt will lead the Global Regulatory Submissions Services business
RSG offers complete regulatory submission service
Submission-ready documentation now provided through Regulatory Services Group
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