Company Overview

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.
knowledge
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.
German Office
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.
Multidisciplinary Team
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.
Approach and Philosophy
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.
Services
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.
Product Experience
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.
Training and Education