Services

LRSS provides strategic and operational support in Regulatory Affairs & Drug Dveelopment development, as well as support in the assessment of data and their presentation.

This support is reflected in the following services:

• Analysis of / advice on development plans

• Scientific writing or review of – any documents relevant to the project from business plan up to study reports

• Position papers and Gap Analysis

• 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