August 27, 2014 4:33 PM ET

Healthcare Providers and Services

Company Overview of RRD International, LLC

Company Overview

RRD International, LLC, a product development company, provides strategic and operational support services for product development, evaluation, and identification programs for the biotechnology, pharmaceutical, and medical device companies. It offers product development services, such as creating and managing domestic and global product development programs, such as scientific, medical, clinical, regulatory, toxicology, manufacturing, patent review, and market assessment for biotech, pharmaceutical, and medical device products; product development support services, including strategic planning, protocol design, project management, clinical trial management, regulatory affairs support, prepar...

7361 Calhoun Place

Suite 325

Rockville, MD 20855

United States

Founded in 2002

Phone:

301-762-6100

Fax:

301-762-6154

Key Executives for RRD International, LLC

Co-Founder
Co-Founder
Vice President of Operations
Managing Director and Executive Vice President
Compensation as of Fiscal Year 2014.

RRD International, LLC Key Developments

Dipexium Pharmaceuticals, Inc. Enters into Amendment to Its Product Development Agreement with RRD International, LLC

On May 22, 2014, Dipexium Pharmaceuticals Inc. entered into an amendment to its Product Development Agreement, dated January 1, 2014, with RRD International, LLC. Pursuant the Amendment, the parties agreed upon a new scope of services and budget to commence preparation of a New Drug Application to be submitted to the FDA for Pexiganan Cream 0.8% (Pexiganan) if and to the extent the company successfully completes its pivotal Phase 3 clinical studies and otherwise successfully completes the Pexiganan drug development program. The Amendment also addresses, among other things, certain medical monitoring (and related) activities, the addition of a new Phase 1 Site Monitor, and the addition of additional fees and pass-through expenses to the development budget.

RRD International, LLC and Dipexium Pharmaceuticals, LLC Form Partnership to Advance Locilex Through Clinical Trials

RRD International, LLC, announced a partnership with Dipexium Pharmaceuticals, LLC to develop Locilex (pexiganan acetate cream 1%), a broad spectrum, small peptide topical antibiotic for the treatment of mild to moderate skin infections in superficial wounds. The company reported that in addition to strategic oversight of the development program, RRD will be operationally responsible for executing the clinical program, including interfacing with the FDA, trial management and vendor contracting and coordination. The clinical program includes completion of two Phase 1 studies (DPX-110 and DPX-120) for skin irritation and skin sensitization and two Phase 3 registration trials (DPX-305 and DPX-306) in patients with mild infections of diabetic foot ulcers. Additionally, to meet its specific requirements, Dipexium was seeking a partnership with RRD that provided ongoing senior-level, strategic guidance through the formation of a dedicated product development team and a financial structure consisting of a fixed-fee development budget and equity participation by RRD.

RRD International Announce Partnership with Dipexium Pharmaceuticals to Develop Locilex

RRD International, LLC (RRD) announced a partnership with Dipexium Pharmaceuticals, LLC (Dipexium) to develop Locilex(TM) (pexiganan acetate cream 1%), a broad spectrum, small peptide topical antibiotic for the treatment of mild to moderate skin infections in superficial wounds. Working closely with Dipexium's senior management under a product development team (PDT) structure, RRD will provide strategic, regulatory and operational support to advance Locilex through clinical trials and New Drug Application (NDA) submission. In addition to strategic oversight of the development program, RRD will be operationally responsible for executing the clinical program, including interfacing with the FDA, trial management and vendor contracting and coordination. The clinical program includes completion of two Phase 1 studies (DPX-110 and DPX-120) for skin irritation and skin sensitization and two Phase 3 registration trials (DPX-305 and DPX-306) in patients with mild infections of diabetic foot ulcers.

Similar Private Companies By Industry

Company Name Region
Grand Rapids Opthalmology PC United States
National Dentex Corporation United States
FCB Healthcare United States
Beechknoll Community United States
Xtend Healthcare LLC United States

Recent Private Companies Transactions

Type
Date
Target
No transactions available in the past 12 months.
 

Stock Quotes

Market data is delayed at least 15 minutes.

Company Lookup

Most Searched Private Companies

Company Name Geographic Region
Bertelsmann AG Europe
Lawyers Committee for Civil Rights Under Law United States
NYC2012, Inc. United States
Rush University United States
Citizens Budget Commission United States

Sponsored Financial Commentaries

Sponsored Links

Report Data Issue

To contact RRD International, LLC, please visit www.rrdintl.com. Company data is provided by Capital IQ. Please use this form to report any data issues.

Please enter your information in the following field(s):
Update Needed*

All data changes require verification from public sources. Please include the correct value or values and a source where we can verify.

Your requested update has been submitted

Our data partners will research the update request and update the information on this page if necessary. Research and follow-up could take several weeks. If you have questions, you can contact them at bwwebmaster@businessweek.com.