• Clinical Trials Services
  • Clinical Plan
  • Regulatory Affairs
  • Monitoring, Logistics & Quality Control
  • Data Management & Statistics
  • Medical Writing

• Epidemiological studies & surveys

• Staffing Solutions

• Biotechnology & Diagnostics

• Pharmacovigilance

• Patient Education Programs

• Technology & e-Clinical

Regulatory Affairs

In Spain, the regulation of clinical trials is being coordinated through EU directives. Regulatory acts are often changing, therefore expertise is essential. Our aim is to assist you with a broad range of regulatory affairs services that can help you in successful submission at the shortest time possible for all the phases of the drug development and approval process.

• Preparation and submission of complete range of regulatory documents
• Obtain permission to conduct clinical trial
• Advice on regulatory procedures
• Preparation and submission of Marketing Authorization (MA) applications
• Local accompanying of central processes
• Provision of official documents, specific procedures and translations
• Expert Reports
• Post Marketing Services: MA transfer, administrative changes, MA variations, pricing, reimbursement, MA renewal

We provide Regulatory Services for:

• Clinical Trials with Drugs
• Clinical Trials with Sanitary Products, Cosmetics, Natural Products, etc
• Post-Authorization Studies (in Spain, they have specific regulation)
• Epidemiological and Pharmacoeconomic Trials
• Non-commercial Clinical trials

AInfociencia publishes the “Survival Guide to Clinical Trials in Spain”, (Guía de Supervivencia en Estudios Clínicos), that will help you in the process of implementing your Clinical Trial in Spain.

This guide is free. Please contact masinformación@infociencia.comif you need a copy.