Regulatory Affairs

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  ERA Consulting Group is one of the longest established and most experienced consulting groups serving the biopharmaceutical industry. Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development strategy and regulatory requirements. Biopharmaceutical products and biomarkers are our particular speciality.
  

• →How we can help

  ERA has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond.

  Our expertise covers a wide range of products (around 400 products to date), incorporating recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products comprising gene therapy, somatic cell therapy and tissue-engineered products.

  We also consult on innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases. Last, but not least, the ERA team includes specialists for companion diagnostics and biomarkers, offering dedicated services in this cutting edge field.

  Our team of more than 30 professionals includes scientists with a research and development background, those with extensive industry experience and former regulators, offering both breadth and depth of expertise, from which our clients can benefit.  ERA has office facilities in Germany, the UK, the USA and Australia, with the in-house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group.
  

• →Our Offer to LBIC Clients

  A free 2-hour strategy meeting or teleconference with key members of the ERA Consulting team. This will be essential for defining the most efficient and productive strategy for progressing the development of your product. ERA is pleased to offer its services to LBIC clients on an ongoing basis. As part of our offering we are pleased to provide our services to LBIC clients at a discounted rate. 
  

• →Contact ERA Consulting

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