Your scientific and regulatory partner for the development of your innovative products
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)
Do you need support or more information about the services? Contact us!
Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”
Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure".
New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU
The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the European Union (EU).
Commission Implementing Decision C(2020) 2532
The European Commission (EC) has published a Commission Implementing Decision requesting a review (standardisation) of a set of existing standards, as well as new standards to be drafted, for support of Regulations 2017/745 (MDR) and 2017/746 (IVDR).
Asphalion is proud to be sponsor of the Online Strategy Meeting on CMC & Regulatory Affairs!
Asphalion will participate in the Online Strategy Meeting on CMC & Regulatory Affairs. Our RIM and data management expert, Marcos Fernández will provide a presentation on IDMP and the impact in regulatory affairs.
WEBINAR | MDR postponed: an opportunity that cannot be missed
Dominique Monferrer, one of our medical devices expert, held this free webinar on the postponement of the MDR, with an analysis of its impact and potential opportunities for the sector.
