Asphalion, S.L.- Spain


1) Regulatory Roadmaps

  • Strategic regulatory and scientific assessment by providing CMC, non-clinical and clinical development plans, to bring your product to the patient in the most efficient way
  • Feasibility assessment, including overview of development timelines and costs

2) Scientific Advice

  • Preparation of briefing packages and attendance to the meetings with authorities
  • National Competent Authorities (NCAs) in Europe
  • EMA: Scientific Advice, Protocol Assistance, Innovation Task Force (ITF)

3) Orphan Drugs Designation (ODD)

  • Management of Orphan Drug Designation (ODD) procedure including presubmission
  • Preparation of Orphan Drug Designation (ODD) applications including significant benefit, prevalence calculation and medical plausibility
  • Experience with both EMA and FDA

4) Support in Clinical Trial Application in EU (preparation and submission)

  • Preparation of Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB)
  • Clinical Trial Application (CTA) submission in EU
  • Adhoc support during Clinical Trial conduction
  • IND Preparation and Submission

5) Advanced Therapy Medicinal Product (ATMP) Specific Services

  • CMC consultancy
  • Preclinical and clinical regulatory advice
  • GMO Submissions
  • ATMP classification and certification
  • Long-term project management and consulting with investigator groups and biotech companies

6) Regulatory Tools

  • Classification of your company as SME (Small Medium Enterprise)
  • PRIority MEdicines (PRIME) and accelerated assessment
  • Qualification of novel methodologies
  • Paediatric Investigation Plan (PIP) and Pediatric Study Plans (PSPs)