O3ZONE SERVICES
O3Zone provides comprehensive regulatory support, by offering consultancy and compliance services to ensure the safe and compliant use of oxygen and ozone as active substances.
Regulatory Affairs
We support pharmaceutical, nutraceutical, cosmetic and medical companies in the development and regulatory compliance of their products in Italy and internationally.
What we offer:
- Regulatory consultancy and CRO services
- End-to-end support for development, manufacturing and clinical studies
- A multidisciplinary team with scientific, regulatory and clinical expertise
All with the goal of accelerating therapeutic innovation, ensuring safety and scientific quality, and guaranteeing compliance with international regulations.
Regulatory Services
- Formulation development and regulatory compliance assessment
- Labelling and informational materials (EU Reg. 1169/2011)
- Notifications and technical dossiers (Ministry of Health, EFSA, EUDAMED)
- Management of registration procedures for food supplements, FSMPs, medical devices, cosmetics, pharmaceuticals and novel foods
CRO Services
We support pharma, biotech and medical device companies in the management of clinical studies, following GCP standards and leveraging advanced digital solutions.
- Protocol design, CRFs and feasibility studies
- Operational management: monitoring, site management, documentation
- Data Management & Biostatistics
- Authorisation procedures for clinical studies on pharmaceuticals, medical devices, food supplements, FSMPs and cosmetics
- Clinical studies for food supplement health claims
Pharmacovigilance & Safety (adverse event management, PSUR, DSUR)
Additional Services
- Pharmacovigilance, cosmetovigilance, nutrivigilance and medical device vigilance
- Management of healthcare advertising submissions
- Scientific review and validation of claims
Representation and administrative procedures with authorities
Therapeutic Areas
- Oncology
- Rare diseases
- Immunology
- Cardiovascular
- Metabolic
- Neurology
- Psychiatry
- Gastroenterology
- Gynaecology
- Urology
- Aesthetics
- Sports medicine
- Dermatology
Why Choose Us
- Scientific and tailored approach
- Cross-sector expertise
- Speed and accuracy
- Continuous support
- A single partner for development and compliance
