The ERA Consulting Group (ERA) and Hybrid Concepts International (HCI) announced on 8 October that they have entered into a collaboration agreement in order to more efficiently and effectively support global clients in response to the growing global demand for strategic regulatory support for companies developing cell and gene therapy products, regenerative medicines, and other advanced therapies. 

The combination of ERA’s and HCI’s respective areas of expertise and experience will further enhance the services offered to current and future clients, including CMC, cGMP manufacture, preclinical, clinical and strategic regulatory affairs, Quality/cGMP services, eCTD-compliant submissions (INDs, BLAs, Master Files, CTAs, MAAs, others), product and technical due diligence, and related project management.  
As a result of this new partnership, ERA and HCI have consultants based in the United States, Canada, Germany, UK, and Australia; this increased geographic presence enables the companies to support clients across Europe and North America, as well as Australia, Japan, China, and South Korea.  

This collaboration agreement does not impact current or future dealings that HCI or ERA may have with existing or future clients outside of this collaboration agreement. 
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