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)
• FDA: INTERACT, Pre- BLA/NDA, PRE-IND, EOP2

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)