| The ERA Consulting Group |
We are an international organisation providing consulting services
in product development and regulatory affairs. We have particular expertise in the
field of biotech and other biological products, innovative NCEs and biomarkers.
Over the past 22 years, we have assisted clients from all over the World to achieve
efficient and expedient regulatory approvals in Europe, the USA and Australasia.
Our clients range from the largest pharmaceutical companies to biotech start-ups
and investment groups. Our proven track record places us in an unrivalled position
as consultants in these fields and provides a level of expertise and experience from
which all our clients can benefit. We cordially invite you to contact us for more
information on our consulting organisation. We would be delighted to have the
opportunity to present ourselves in more detail in a personal meeting. |
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| Office Locations |
ERA's head office is located in the northern town of Walsrode, close
to the cities of Hamburg, Hannover and Bremen. It is here that our central
administrative group is located, together with our dedicated IT and eCTD teams. Our
largest consulting office is in London's Docklands, in the proximity of the European
Medicines Agency. Here, we have the capabilities to prepare complete submissions and
prepare for agency meetings, as well as offering our consulting and European
Regulatory Intelligence services. Our US office in Washington, DC, is convenient for
our FDA-focussed activities and provides the base for our joint-venture, US Biologics
Regulatory Services. ERA's Australian office is in Brisbane, within the cluster
around the Queensland Clinical Trial Network. This provides a logistically ideal
location for ERA's extensive activities in the Pacific Rim region. |
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| Multidisciplinary Team |
Our team, comprising more than 30 professionals, combines thorough
knowledge and understanding of regulatory directives and guidelines with considerable
scientific sophistication. In particular, our team is experienced in the issues
associated with cutting edge biopharmaceutical products. For this, we have established
a multidisciplinary team with expertise in the fields of molecular and cell biology,
protein biochemistry, immunology, pharmacology, manufacture, quality control,
validation, facility qualification and electronic submissions. The scientific project
team is supported by a technical infrastructure, providing in-house IT capabilities,
electronic document processing and dossier compilation. Most importantly, the team
across our four locations is fully integrated, so that major projects may involve
input from consultants in several of our offices. |
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| Approach and Philosophy |
As successful service providers for the past two decades, we are well
aware of the importance of meeting or exceeding the expectations of our clients. It
is true to say that requirements differ from client to client, and it is our
responsibility to ensure that we understand the specific goals of a client, and we
strive continuously to utilise our resources to perform to the satisfaction of the
client, in terms of quality and expediency of our services. For most tasks, we appoint
a project manager at ERA, as the primary interface with the client and coordinator
for the project activities within ERA. This underscores our approach and philosophy,
to relieve the client of any burden associated with the provision of ERA's services.
Last, but not least, it is our goal to be proactive rather than reactive, applying
creativity to discovering and implementing the most efficient possible approach to
problem solving. |
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| Services |
ERA is able to contribute at any stage of product development, from
discovery, through process development, non-clinical and clinical aspects, to
regulatory approval and beyond. One of our recognised specialities is the design of
a regulatory strategy, to cover part or all of the development process. Thus, our
services include the following: Regulatory due diligence exercises for in- or
out-licensing, interactions with regulatory agencies, such as pre-IND, pre-BLA and
scientific advice procedures, clinical trial applications, marketing authorisation
applications, including eCTD submissions, post-approval amendments or variations,
advice on process development, including validation, input on characterisation and
control, consulting on non-clinical and clinical strategy, facility inspections and
support for establishment licensing. |
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| Product Experience |
To date, ERA has undertaken tasks and accumulated experience on
around 400 products. Apart from innovative new chemical entities, our specialities
cover products of recombinant DNA technology and conventional biologics, such as
hormones, cytokines, other therapeutic polypeptides, receptor agonists or
antagonists, enzymes, monoclonal and polyclonal antibodies, products derived from
animal sources (e.g. from ruminant animals for certification), blood products,
herbal medicinal products, vaccines, gene, cell therapy and tissue engineered
products, combination products, companion diagnostics and biomarkers. To this end,
we have experts within the organisation for the various types of product, both
human and veterinary. It is our practice to build a team within ERA, having the
appropriate qualifications and experience for the particular product and task in
hand. |
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| Security and Confidentiality |
ERA takes the confidentiality of our clients' intellectual property
very seriously. We are well aware of the sensitive nature of much of the data and
information provided to us by our clients. Our project work is conducted under
confidentiality or non-disclosure agreements. The employment contracts of our team
members include rigorous confidentiality requirements, which continue beyond their
period of employment with ERA. In our 22-year history, there has been no case of
breached confidentiality, and we consider this to be essential to our reputation.
Our offices maintain state-of-the-art security systems, including intruder alarms
and surveillance systems, as well as IT protection measures. While it would
obviously be inappropriate to provide details here, we are always willing to
demonstrate our security measures to our clients. |
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