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
  • 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.
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