Dunn Regulatory Associates, LLC
Dunn Regulatory Associates, LLC offers expert US Agent services for non-US firms entering the US pharmaceutical market. Leverage their scientific acumen and regulatory expertise for effective FDA communications and compliance.
Dunn Regulatory Associates, LLC provides specialized US Agent services, acting as a reliable and competent representative for international companies seeking to enter the US pharmaceutical market. Their team of consultants possesses deep scientific acumen and regulatory expertise, strategically located in the Washington, DC metropolitan area, making them an ideal choice for global clients. They streamline product development from discovery to market by integrating scientific knowledge, business strategy, and regulatory expertise. Dunn Regulatory Associates, LLC has a proven track record in resolving complex regulatory situations for Rx and OTC pharmaceuticals, biopharmaceuticals, and devices. Their services include gap analysis of regulatory submissions, ensuring compliance with all applicable laws and regulations, facilitating effective communications with the FDA, and participating in FDA meetings and teleconferences. Their consultants are experienced US and EU regulatory strategists, offering pragmatic approaches to regulatory challenges, developing concise strategies, and leading regulatory meetings. Dunn Regulatory Associates, LLC is committed to providing sound solutions and expert advice to companies across the globe, ensuring a smoother path to market entry and regulatory success.
About
**Who they are**
Dunn Regulatory Associates, LLC is a regulatory consulting firm that offers expert US Agent services for non-US firms aiming to enter the US pharmaceutical market. They leverage scientific acumen and regulatory expertise for effective FDA communications and compliance.
**Expertise & scope**
* Integrated regulatory and scientific consulting services for the global healthcare industry.
* Specialized US Agent services for international clients seeking entry into the US pharmaceutical market.
* Support for navigating FDA communications and ensuring compliance with applicable laws and regulations.
* Gap analysis of regulatory submissions.
* Consulting services encompass nonclinical, clinical, CMC, and compliance areas.
* Expertise in regulatory strategy and medical writing.
**Reputation / proof points**
* Strategic location in the Washington, DC metropolitan area.
Dunn Regulatory Associates, LLC is a regulatory consulting firm that offers expert US Agent services for non-US firms aiming to enter the US pharmaceutical market. They leverage scientific acumen and regulatory expertise for effective FDA communications and compliance.
**Expertise & scope**
* Integrated regulatory and scientific consulting services for the global healthcare industry.
* Specialized US Agent services for international clients seeking entry into the US pharmaceutical market.
* Support for navigating FDA communications and ensuring compliance with applicable laws and regulations.
* Gap analysis of regulatory submissions.
* Consulting services encompass nonclinical, clinical, CMC, and compliance areas.
* Expertise in regulatory strategy and medical writing.
**Reputation / proof points**
* Strategic location in the Washington, DC metropolitan area.
Additional information
Dunn Regulatory Associates, LLC is conveniently located near Tysons Corner, VA, a significant corporate hub. This location offers access to numerous hotels, restaurants, and meeting spaces, making it a practical choice for business meetings. The firm emphasizes providing pragmatic advice and sound solutions for product development, working closely with clients through every stage of their product's journey to market.
Key Highlights
-
Offers expert US Agent services for non-US firms entering the US pharmaceutical market.
Source
“As a non-US firm seeking entry into the US pharmaceutical market, your first obstacle is finding a reliable and competent US representative.”
-
Leverages scientific acumen and regulatory expertise for effective FDA communications and compliance.
Source
“The scientific acumen and regulatory expertise of our consultants, along with a strategic location in the Washington, DC metropolitan area, make DRA a logical US Agent choice for our international clients.”
-
Provides gap analysis of regulatory submissions and ensures compliance with applicable laws and regulations.
Source
“Gap analysis of your regulatory submissions Compliance with all applicable laws and regulations”
-
Consulting services cover nonclinical, clinical, CMC, and compliance areas.
Source
“Consulting Services Nonclinical Clinical CMC Compliance”
Certifications & Trust Signals
-
Strategic location in the Washington, DC metropolitan area.
Source
“along with a strategic location in the Washington, DC metropolitan area, make DRA a logical US Agent choice for our international clients.”
Buyer Snapshot
Best for
- Non-US firms seeking entry into the US pharmaceutical market
- Companies needing a reliable and competent US representative
How engagement typically works
- Collaborative, working closely with clients through every stage of product development
- Providing pragmatic advice and sound solutions
Typical deliverables
- US Agent representation
- FDA communications support
- Regulatory compliance
- Gap analysis of regulatory submissions
- Regulatory strategy development
- Medical writing
Good to know
- Best when requiring specialized US Agent services for pharmaceutical market entry.
HQ:
Vienna, USA
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Product Type:
devices
Additional us_agent_fda Details
Product Types
Pharmaceuticals
US Entity State
VA
