DRUG DEVELOPMENT AND REGULATION (DDR)

High-Quality Scientific and Regulatory approach to


Development of New Drugs

Efficient Management of
Drugs' Life Cycle

Regulation of Medicines

DDR provides strategic, independent and global consulting services focused on Drug Development and Drug Regulation to effectively contribute to on the development and successful conclusion of projects.

DDR offers consulting services and hands-on support through our own capabilities and the DDR's Network: highly qualified and experienced experts from regulatory, academia, industry and other well recognized consulting companies across Europe, USA, Japan and Latin America.

The DDR's Network provides appropriate expertise, knowledge and capabilities for a global approach.

Contact us at info@ddrmedic.com to discuss your requirements.

Practice Area Focus:

  • EU Regulatory Strategy
  • European registration through the Centralized and the Mutual Recognition/Decentralized procedures
  • EMA: Orphan Drug Designations, Scientific Advice, Briefing Meetings
  • European Member States: scientific advices and other consultations
  • USA: IND and NDA
  • Post Marketing authorization activities
  • Drug Development Strategy
  • Benefit-Risk Assessment
  • Pharmacovigilance
  • Drug Safety
  • Medical Affairs
  • Several therapeutic areas including Oncology, Infectious Diseases, Central Nervous System, Diabetes, Cardiovascular, Respiratory, Gastro-intestinal, Inflammation and Immunology