Dunn Regulatory Associates LLC
Homepage http://www.dunnregulatory.com
LinkedIn Profile https://linkedin.com/company/dunn-***-associat***
HQ Location
United States , Virginia, Oakton2709 Silkwood Ct Oakton, VA United States
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
Pharmaceuticals and Medicine Manufacturing
The Drugs and Medicine industry involves research, development, manufacturing and distribution of pharmaceutical drugs and medicines. Companies in this field focus on preventing and treating illness using medicinal compounds and therapies.
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