GMP SOLUTIONS
MolMed S.p.A. is a biotechnology company with a key expertise in cell and gene therapies.
MolMed’s in-house GMP facility is formally authorised by the Italian Pharmaceutical Agency (AIFA) for production and release of medicinal products, and complies with the requirements of current legislation and best practice guidelines for the manufacturing of patient-specific or genetically modified cells and active pharmaceutical ingredients for clinical use.
MolMed’s service area, “GMP Solutions”, provides tailor-made services for your cell and gene therapy projects: it offers top-level expertise to develop, conduct and validate custom studies, devising innovative testing procedures and addressing the unique test specifications required for novel cell-based therapeutics.
For MolMed, customer satisfaction is of utmost importance, and it is guaranteed by the strict compliance with the current guidelines issued by all the relevant international regulatory authorities.
GMP Solutions is a reliable partner for both academy and industry that want to bring a project from early stage to advanced clinical development: GMP Solutions provides tailored advice and extended services to meet customers' needs and expectations:
- Feasibility studies
- Development activities
- Support for regulatory affairs
- Validation of computer systems
- Validation of processes, methods and suppliers
- Production and control of materials pre-GMP
- Production and quality control of products for clinical use
- Project Management
- Training activities and audit
- Advice for grant application
