p36 is an IT company founded and located in the heart of Germany, in Bad Hersfeld. p36 develops and operates cloud-based Software-as-a-Service solutions with high quality standards for the Life Sciences industry based on special expertise in regulatory topics and more than 15 years of experience as SAP Cloud Consulting Partner.
Obelis is a quality driven, service-oriented company based in Brussels, Belgium with over 30 years of experience in regulatory affairs. Obelis operates as one of the largest regulatory centres in Europe today providing Authorized Representative (EC REP) services.
Syntactx is a clinical research partner with significant expertise in complex interventional medical device and pharmaceutical trials across multiple therapeutic areas. Syntactx has a long history of synthesizing clinical evidence to enable broad market adoption of innovative products.
Evnia is a specialist consultancy firm that prepares compliant clinical evaluation reports, technical documentation, and IVDR performance evaluation reports for manufacturers. Evnia has deep cross-functional experience and know-how, involving a wide range of professionals, such as medical doctors, biostatisticians, medical and clinical writers, and engineers, who work collaboratively to ensure a holistic approach towards compliance.