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Articles

June 3, 2014

REGULATORY MANAGEMENT – Renewed Focus on Reg IM as Commercial Takes Center Stage June 3, 2014

Joel Finkle emphasizes that as companies start to shift their thinking toward their commercial needs, they’re coming to realize that the regulatory function plays a crucial role in securing and maintaining market access and that Reg IM is more than simply a useful submission tool – that it is essential to managing the big picture.

January 13, 2017

COMBINATION PRODUCTS – 6 Guidelines to Follow When Developing Combination Products January 13, 2017

Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.

March 28, 2016

NDA Group & PharmApprove Announce Merger March 28, 2016

NDA Group and PharmApprove recently announced their merger. The newly combined company will allow clients to streamline the global development...
March 31, 2015

SPECIAL FEATURE – Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products March 31, 2015

Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.

Company Profiles

August 14, 2018

Noble

Noble 121 South Orange Avenue Suite 1070 North Orlando, FL 32801 T: (888) 933-5646 E: info@gonoble.com Website: www.GoNoble.com   Founded...

Issues

May 2, 2018

March 2008

The Management Buy-Out: What's a Fair Price?Derrek G. Hennecke, MBA, continues with part 2 of his 7-part series chronicling the...