Excellence in Drug Regulatory Affairs

Our Services

EXDRA as renowned full service provider offers the following broad range of regulatory services:

Research & Development
  • Early Scientific Advice with authorities
  • Project planning
    – according to international registration standards
    – following Scientific Advice
  • Clinical Trial Application
    – Investigator’s Brochure (IB)
    – Investigational Medicinal Product Dossier (IMPD)
    – Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) for Investigational Medicinal Products (IMPs)
  • Optimization of clinical research spending
  • Project management
    – Minimizing administrative burden by effective document management
  • Support for in-house registration of Medicinal Products and Medical Devices
    – Evaluation of good regulatory practice (GRP), Regulatory compliance and Quality Management (QM)
    – Due diligence of existing in-house data/documents
    – Evaluation of existing regulatory intelligence
    – Analysis of regulatory requirements in target markets
    – Development of an international registration strategy
    – Pricing policies/ Pharmaco-economics
    – Maximizing patent protection/SPC
    – Business-optimized registration procedures: Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP) and single country procedure
  • External full-service provider
    – Filing of US- and Japanese applications with partners
    – Monitoring upcoming requirements
  • Good manufacturing and distribution practice (GMDP)
  • Drug master files (DMF)
  • Active substance master file (ASMF)
  • Certificate of Suitability (CEP) issued by the European Directorate for the Quality of Medicines (EDQM)
  • Worldwide Inspection Policy and Strategy
Business Development
  • Merger and Acquisition (M&A) activities
    – Company Due Diligence (Pharma, Biotech and Medical Device)
  • Business Development support
  • Due Diligence of existing registration dossiers
  • Regulatory life cycle strategy
Marketing and Sales
  • Support in pricing strategies
  • Pharmaco-economic modelling
  • Health Technology Assessment
  • Life cycle management
  • Variations and extensions (new dosage forms, new strenghts, new indications)
  • Optimized labelling


Further EXDRA Services
  • exdra Academy
    – In-house seminars
    – Specialty workshops
    – MSc based education
  • Human resources management
    – Interims management
    – Recruitment of necessary competence profiles
    – Assessment of qualifications
  • Document management
    – Process and workflow definition
    – Software tool implementation