Oktal Pharma offers local support in regulatory affairs and pharmacovigilance, and a wide range of regulatory and pharmacovigilance services for medicinal products, medical devices, food for special medical purposes, cosmetic products and food supplements. Available services also include:
- Maintaining the marketing authorisation throughout the product life cycle (preparing and submitting registration documentation and requests to the regulatory Authorities),
- Monitoring and implementation of regulatory requirements,
- Review of promotional materials,
- Services of the local responsible person for pharmacovigilance (local QPPV) and deputy,
- Local pharmacovigilance system and all necessary local pharmacovigilance activities (handling reports of adverse events, local scientific and medical literature screening, education, implementation of risk minimisation measures and others),
- Local vigilance and cosmetovigilance systems.