Support Service for the Development of Advanced Therapy Medicinal Products (ATMPs) & Biologics

At Asphalion, we support you with the development of Advanced Therapy Medicinal Products (ATMPs) and Biologics.

Our experts have extensive experience in the development and regulatory assessment of ATMPs. They also support the management of Orphan Drug Designation (ODD), and in the Application for Clinical Trials in the EU and USA (preparation and submission).​

Advanced Therapy Medicinal Products (ATMPs) Services We Support

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 (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

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

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

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)

Advanced Therapy Medicinal Product (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)