Regulatory affairs


• Regulatory Road Map

• Scientific advice (national and EMA)

• Orphan Drug Application

• Pediatric Investigational Plan

• Centralized procedure with EMA

• Decentralized procedure

• Mutual Recognition Procedure

• Briefing document for Regulatory purpose or business

• Investigator Brochure

• Investigational Medical Product Dossier (IMPD) nonclinical and clinical

• Investigational New Drug (IND)

• Meeting with FDA (A, B ( pre-IND, EOP2), C)

• Special Protocol Assessment (SPA)



By asking LRSS to take care of a study, YOU as the client may expect:

  • High quality document meeting regulatory requirements and internal standard
  • Integrated approach in document’s preparation
  • Optimal interaction with Regulators based on years of experience
  • Going beyond the classical view for preparation and implement