Healthcare Providers and Services
Company Overview of RRD International, LLC
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
Rockville, MD 20855
Founded in 2002
Key Executives for RRD International, LLC
Co-Founder, Chief Executive Officer and Managing Director
Co-Founder, Chairman, Managing Director and Chief Scientific Officer
Chief Financial Officer and Senior Vice President
Vice President of Operations
Compensation as of Fiscal Year 2014.
RRD International, LLC Key Developments
RRD International Announces Management Changes
Oct 21 14
RRD International announced the addition of Brian R. Gallagher, CMA, to the executive team. Gallagher joins RRD as senior vice president and chief financial officer, bringing more than 20 years of finance experience from the biopharma industry, with both multi-national corporations and commercial-stage public biotechnology companies. Robert L. Smith, Jr., CPA, the current senior vice president of finance and administration, will be retiring at the end of the calendar year. Brian Gallagher's previous experience includes positions at Merck & Company and Adolor Corporation. Most recently, Gallagher was vice president of finance for Optimer Pharmaceuticals.
Dipexium Pharmaceuticals, Inc. Enters into Amendment to Its Product Development Agreement with RRD International, LLC
May 29 14
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
Feb 15 14
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.
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