Tender for The purpose of the framework agreement is the selection of two (2) companies for each lot, specialized in regulatory consulting in life sciences, intended to provide services to the r+d+i projects of the Fundació Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR). Specifically, the following services are required: 1) preparation of regulatory roadmaps for the categories drugs, "medical devices" and "in vitro diagnostics"; 2) preparation of queries and scientific advice with regulatory agencies (EMA, FDA and AEMPS); 3) preparation of the specific technical documentation necessary to obtain regulatory approval. 4) assistance with applications for orphan drug designation, PRIME and similar. The framework agreement is divided into two lots: • Lot 1: regulatory consulting specialized in drugs ("small molecules", biologicals, advanced therapies, and combination products). • Lot 2: regulatory consulting specialized in medical devices (MD), in vitro diagnostics (IVD), and software related to each category including AI.