ERA Consulting Group

ERA Consulting Group and Hybrid Concepts International Announce Collaboration Agreement to Expand Strategic Cell & Gene Therapy Regulatory Services

The ERA Consulting Group (ERA) and Hybrid Concepts International (HCI) announce today they have entered into a non-exclusive 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.

For Immediate Release (PDF):

The ERA Consulting Group is one of the longest established and most experienced strategic regulatory consulting groups serving the biopharmaceutical industry.

ERA has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond. Over the last 25 years ERA has worked on more than 500 products, including advanced therapy medicinal products comprising gene therapy, somatic cell therapy, stem cells, gene editing and tissue-engineered products. ERA has extensive experience working with FDA, EMA, PMDA and TGA covering multiple agency interactions including over 10 years’ experience with eCTD filings.

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Michael Mendicino