Dunn Regulatory Associates, LLC

Pharmaceutical ManufacturingUnited States11-50 Employees

Our Focus
Dunn Regulatory Associates, LLC’s focus is to provide superior regulatory strategy, US Agent Services, and regulatory document preparation for the development of Rx and OTC pharmaceuticals, biopharmaceuticals, devices, and cosmetics.  Using an experienced based approach that provides strategic, scientific and regulatory integration, our firm’s goal is to streamline your development efforts. The firm’s focus includes:
	Developing pragmatic approaches to regulatory issues
	Developing concise and thorough regulatory strategies
	Negotiating with the FDA and EU
	US Agent services including IND maintenance
	Writing, managing and reviewing all modules of the CTD, IB, and meeting packages
	Utilization of expedited regulatory pathways including Breakthrough therapy
	Strategic product placement
	Preparation of Integrated Development Plans

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