Support during development of ATMPs and Biologics.

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

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

Orphan Drugs Designation

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

Clinical Trials

• 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

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

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)

ATMP and biologic product expertise:

Oncolytic viruses · Adeno-associated virus (AAV) · Modified Vaccinia Virus (MVA) · Plasmids · Lentivirus · Adenovirus (AdV) · CAR-T · Mesenchymal stem cells · Bone marrow-derived hematopoietic stem cells · Adipose-derived stem cells · Aptamers · Antibodies · Biologics · Vaccines · Personalised medicine · Tissue engineered products · Dendritic Cells (DCs)