Tenders Are Invited For Framework Agreement For The Approval Of A Total Of 4 Companies Specialized In Regulatory Consulting In Life Sciences Intended To Offer Services To The R+D+I Projects Of The Vall Hebron University Hospital Foundation – Institut De Recerca (Vhir).

Framework Agreement For The Approval Of A Total Of 4 Companies Specialized In Regulatory Consulting In Life Sciences Intended To Offer Services To The R+D+I Projects Of The Vall Hebron University Hospital Foundation – Institut De Recerca (Vhir)..The Object Of The Framework Agreement Is The Selection Of Two (2) Companies For Each Lot, Specialized In Regulatory Consulting In Life Sciences, Destined To Offer Services To The R+D+I Projects Of The Fundació Hospital Universitari Vall Hebron-Institut De Recerca (Vhir). Specifically, Services Related To The Following Activities Are Required:1) Preparation Of Regulatory Roadmaps For The Categories Drugs, “Medical Devices” And “In Vitro Diagnostics”2) Preparation Of Scientific Consultations And Advice With Regulatory Agencies (Ema, Fda And Aemps)3) Preparation Of The Specific Technical Documentation Necessary To Obtain Regulatory Approval.4) Assistance In 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 Ia.

3,72,000 - EUR

FileName	File Description
Global Tender Document	a1bb5af5-fdd4-405d-8e05-5d1702016c17.html