About ERASave as PDF
With more than 25 years of experience the ERA Consulting Group is one of the longest established and most experienced consulting groups serving the biopharmaceutical industry, ranging from large transnational pharmaceutical companies, to smaller biotech start-ups. ERA has the experience and flexibility to provide individual solutions for all strategic regulatory affairs requirements encompassing investors, academia and industry.
ERA specialises in regulatory affairs consulting services relating to biotechnological and biological products including recombinant proteins, conventional and advanced vaccines, advanced therapy medicinal products (ATMPs), as well as "natural" biologics including blood products and plant derivatives.
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
- Authoring and reviewing of regulatory submissions such as clinical trial applications, paediatric investigation plans, orphan drugs etc.
- 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
- Support for establishment licensing
ERA's dedicated eCTD and IT team as well as the central administrative group is located at our head office in Walsrode, Germany. Additional consulting offices are located in London, UK, Washington DC, USA as well as in Brisbane, Australia.
For further information on other consulting services please see: www.eraconsulting.com