ERA Consulting Group - Regulatory Affairs Consulting for the Biopharmaceutical Industry

Specialist regulatory affairs consulting services to pharmaceutical companies, including scientific and technical aspects, towards the development and registration of biotechnology and biological medicinal products in Europe and the United States. Our team consists of experts in regulatory affairs, product development and manufacture, pre-clinical study design/development and clinical trial design/evaluation. Areas of expertise include: Biologics/biological medicinal products, vaccines, viral products, gene therapy, cell therapy, monoclonal antibodies, products of recombinant DNA (bacterial and mammalian) and hybridoma technologies, immunoglobulins and biologics obtained from natural sources