 |
1987 |
| Founding of the product development and regulatory affairs consulting group
in Germany, that subsequently became ERA; this was the first such consulting
group in Europe, dedicated to biopharmaceutical products |
 |
1988 |
| The consulting group plays a major role in the approval of one of the first
major biotech products to be assessed under the EC Concertation Procedure, as
well as being involved in a considerable number of national and Multistate
procedures |
 |
1993 |
| The consulting organisation becomes ERA as a result of a management buy out
of the business; the consulting group moves into dedicated facilities in the town
of Walsrode, conveniently located in the triangle between the north German cities
of Hamburg, Hannover and Bremen |
 |
1995 |
| ERA's UK subsidiary founded in London, in response to the establishment of the
European Medicines Evaluation Agency (EMEA), the rationale being ERA's
specialisation in biologics, for which the Centralised Procedure through the EMEA
is mandatory |
 |
1996 |
| ERA's US subsidiary, ERA Consulting (USA) LLC, founded in Charlottesville, VA
(subsequently moved to Washington, DC); at this time, ERA's business came
overwhelmingly from US companies, reflecting the predominant position of the US in
biotechnology |
 |
2004 |
| ERA Consulting Group (Australia) Pty Ltd incorporates in Melbourne, VIC, as a
holding company for ERA's activities in the Pacific Rim region; ERA Consulting
(Australia) Pty Ltd founded in Brisbane, QLD, as the group's operating company in
Australia |
 |
2005 |
| ERA purchases and refurbishes the former London Gas Museum, in the Docklands
and in the proximity of the EMEA, to provide a larger facility for UK consulting
operations as a result of growth of the team, as well as offering improved logistic
capabilities |
 |
2006 |
| ERA Consulting (Australia) Pty LLC becomes a member of the Queensland Clinical
Trial Network (QCTN), an initiative of the Queensland Government, as the network's
regulatory experts, and is invited to co-locate at QCTN's office facilities in
Brisbane |
 |
2008 |
| ERA purchases a new facility in Washington, DC, to allow for expansion of US
operations at a convenient location close to Union Station and the Capitol, as well
as providing a base in the nation's capital for US Biologics Regulatory Services
LLC (US-BRS). |
 |
2009 |
| On the basis of ERA's expertise and experience in companion diagnostics and
biomarkers, this becomes formally launched as a distinct service, in response to
the introduction of regulatory procedures in the USA and Europe for the assessment
of biomarkers |
