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Coté Orphan Consulting And The ERA Consulting Group Announce A Strategic Alliance

7/22/2014 12:34:49 PM

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Silver Spring, MD-Coté Orphan Consulting (COC) and the ERA Consulting Group (ERA) are pleased to announce the establishment of a strategic transatlantic alliance to provide comprehensive services to clients developing products for orphan indications.

Coté Orphan Consulting is a regulatory affairs advisory firm, led by Dr. Timothy Coté, former director of the FDA’s Office of Orphan Products Development. During his tenure at the FDA, Dr. Coté personally signed approximately 800 orphan drug designations and was instrumental in enacting the 1983 Orphan Drug Act. Dr. Coté founded COC in 2012 to leverage his expertise in orphan drug development to help biotech and pharmaceutical companies forge successful pathways through the FDA’s regulatory hurdles. Since its inception, the COC team has provided regulatory consulting services including FDA orphan designation applications, breakthrough therapy designations, pediatric priority review vouchers, and regulatory strategic planning to over 150 major biotech and pharmaceutical companies. In an effort to expand its service offerings, COC recently signed a $7 million contract resulting in the establishment of Coté Orphan Clinical Trials, a full-service clinical research organization.

The ERA Consulting Group, with five offices, two in the UK, and one in Germany, Washington, DC, and Brisbane, Australia, is the foremost consulting organization in Europe and Australasia for biologics, including gene and cell therapy products, which are often developed for orphan indications. With more than 27 years of experience, the ERA team is well placed to provide advice and compile documentation for CMC and nonclinical aspects of novel products, and has successfully achieved orphan medicinal product status in the EU for many clients, who then benefit financially from protocol assistance procedures. ERA provides other integral services including scientific advice at EU Member State Agencies and the EMA, which is critical to the development of products for rare diseases. Last, but not least, ERA has full electronic publishing capabilities to process electronic submissions both to FDA and EU authorities.

Together, therefore, COC and ERA can provide advice and practical assistance at all stages of development of orphan drugs, including concept, orphan designation, clinical trial applications, and BLAs/MAAs. Interested sponsors can contact either organization to benefit from the combined services of the alliance.

Coté Orphan Consulting
8630 Fenton Street, Suite 222
Silver Spring, MD 20910, USA
Tel.: +1 202 779 9599

ERA Consulting Group Postfach 1249
29652 Walsrode, Germany
Tel.: +49 5161 98900

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