Eigen Solutions Inc Information

Eigen offers strategic and tactical regulatory services in accordance with FDA/ICH standards for small to mid-sized companies in all phases of drug development. Eigen provides a wide range of support levels to supplement existing scientific and regulatory staff. Eigen can act as a start-up company's head of regulatory affairs, assisting with presentations to the Board of Directors, investors and FDA or foreign equivalent. Eigen can support larger projects such as marketing applications, or provide as-needed assistance during times of high demand. Eigen provides Regulatory Operations, electronic submission, and document management consulting services to the biopharmaceutical industry. We help clients manage complex projects so they can deliver products to market more quickly, improve quality, and reduce overtime. Our team of highly experienced professionals offers a comprehensive set of services covering all aspects of electronic drug regulatory submission business ranging from eCTD and NeeS compilation and Submission Hosting to individual processing of submission documents. In addition we provide Consulting, Trainings and support the implementation of electronic publishing systems and processes in the global pharmaceutical industry.