D&V FARMA srl
Consultancy and product-licensing firm focused on medical devices and dietary supplements. Services combine academic research collaboration and industry professionals to support regulatory certification, clinical and preclinical evidence generation, intellectual property protection, and business development for small and medium pharmaceutical and medtech companies.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Ophthalmic formulations (eye drops and gels)
Multiple ophthalmic sterile formulations for indications such as dry eye, corneal protection, antioxidant protection, photo-oxidative protection, corneal edema and perioperative prophylaxis; available in multidose and single-dose formats.
Prefilled sterile riboflavin syringes for corneal cross-linking
Sterile prefilled syringes containing riboflavin and dextran with penetration enhancers intended for corneal cross-linking protocols.
Surgical dyes for vitreoretinal and anterior capsule staining
Sterile solutions for tissue staining during vitreoretinal surgery, ERM/ILM staining and anterior capsule staining; packaged in small-volume sterile syringes.
Visco-surgical devices (intraocular viscoelastics)
Visco-surgical sterile devices to create and maintain the anterior chamber and protect endothelial cells, provided in prefilled syringe formats.
Cross-linking equipment and compatible consumables
Cross-linking devices supporting epi-off/epi-on protocols and continuous or pulsed CXL modes; paired with compatible consumables.
Diagnostic ocular stain (fluorescein alternative)
Patient-friendly ocular stain presented as a multidose dispenser or single-dose vial for diagnostic use as an alternative to fluorescein.
Ophthalmic formulations (eye drops and gels)
Multiple ophthalmic sterile formulations for indications such as dry eye, corneal protection, antioxidant protection, photo-oxidative protection, corneal edema and perioperative prophylaxis; available in multidose and single-dose formats.
Prefilled sterile riboflavin syringes for corneal cross-linking
Sterile prefilled syringes containing riboflavin and dextran with penetration enhancers intended for corneal cross-linking protocols.
Surgical dyes for vitreoretinal and anterior capsule staining
Sterile solutions for tissue staining during vitreoretinal surgery, ERM/ILM staining and anterior capsule staining; packaged in small-volume sterile syringes.
Visco-surgical devices (intraocular viscoelastics)
Visco-surgical sterile devices to create and maintain the anterior chamber and protect endothelial cells, provided in prefilled syringe formats.
Cross-linking equipment and compatible consumables
Cross-linking devices supporting epi-off/epi-on protocols and continuous or pulsed CXL modes; paired with compatible consumables.
Diagnostic ocular stain (fluorescein alternative)
Patient-friendly ocular stain presented as a multidose dispenser or single-dose vial for diagnostic use as an alternative to fluorescein.
Services
Identification and management of in-licensing and out-licensing opportunities and access to a partner product portfolio for pharmaceutical and medtech companies.
Preparation of clinical evaluation reports, protocol drafting, identification of opinion leaders, study management and data analysis support for pre- and post-market studies.
Design and coordination of biological safety assessments and preclinical tests aligned with ISO 10993-1 and relevant regulatory frameworks.
Preparation of post-market surveillance and vigilance reports to monitor safety and performance of devices on the market.
Manuscript preparation, statistical analysis, journal selection, submission and management of peer-review responses.
Assistance in drafting patent applications, compiling supporting data and responding to patent office communications; occasional financial support for patent filing.
Identification and management of in-licensing and out-licensing opportunities and access to a partner product portfolio for pharmaceutical and medtech companies.
Preparation of clinical evaluation reports, protocol drafting, identification of opinion leaders, study management and data analysis support for pre- and post-market studies.
Design and coordination of biological safety assessments and preclinical tests aligned with ISO 10993-1 and relevant regulatory frameworks.
Preparation of post-market surveillance and vigilance reports to monitor safety and performance of devices on the market.
Manuscript preparation, statistical analysis, journal selection, submission and management of peer-review responses.
Assistance in drafting patent applications, compiling supporting data and responding to patent office communications; occasional financial support for patent filing.
Expertise Areas
- Clinical evaluation and clinical data management
- Regulatory compliance for medical devices (MDR, MEDDEV, ISO 10993)
- Preclinical study design and execution
- Ophthalmic product formulation and surgical adjuncts
Key Technologies
- Biocompatibility assessment (ISO 10993-1)
- Clinical evaluation methodology (MEDDEV 2.7/1, MDR 2017/745)
- Post-market surveillance systems
- Clinical protocol development and management
News & Updates
In the first two years of activity, supported more than 20 companies in registration and response to ministerial objections and contributed to development of about 70 medical devices and dietary supplements.
In the first two years of activity, supported more than 20 companies in registration and response to ministerial objections and contributed to development of about 70 medical devices and dietary supplements.