Documentation

The ERA team has expertise in technical writing, especially in the demanding field of biopharmaceutical products. Our scientists have worked in manufacturing, control laboratories, development genetic or cell biology environments, so that they are able to reflect accurately the scientific content of a regulatory document. ERA offers complete dossier compilation and submission services. With our office locations in London (close to the EMEA) and in Washington, DC, we are logistically well positioned for these tasks.

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Dossier compilation for biopharmaceutical products is by no means a routine task. First and foremost, this requires a good understanding of the product and the process. With a large cumulative experience and expertise in this field, our team is capable of supporting clients by assuming responsibility for part or whole of dossier compilation. This is not done blindly; our team is used to reviewing all the raw data and reports for inclusion in a regulatory submission, ensuring correct content and consistency throughout. All documents and information received at the ERA facilities are logged into a database, and the team ensures that all the required information is included in the dossier, at an appropriate level of detail.

ERA distinguishes itself from many other consulting groups, not only through our experience with biotech products, but also due to our strong technical infrastructure. Our office facilities are designed for extensive dossier compilation efforts, and our scientific writing team is supported by technical staff with an impressive array of high-speed printing and copying equipment. Hence, documents are quality monitored in-house before dispatch. Our locations in London, UK, and Washington, DC, are logistically well-placed for submission to the respective agencies.