Eusano provides extensive analytical and regulatory affairs services in collaboration with our partners, Phytos (analytical services) and HerbResearch (regulatory services).
HerbResearch is experienced in all aspects of regulatory affairs for medicinal product registration or health claim applications for food supplements, medical devices and cosmetics.
Through their network of service providers HerbResearch can:
- Provide registration dossiers in CTD format
- Assist with Health Claim applications
- Safety assessments of plant prepations for regulatory affairs
- Conduct literature reviews
- Provide clinical, pharmacological, toxicological and quality expert reports
- Organise pharmacological, toxicological, and clinical studies
- Conduct Risk-Benefit assessments
- Evaluate adverse event reports
- Assist with other regulatory affairs issues including PSURs, variations
Phytos provides a broad range of analytical services supporting customers from industry and research in development, quality control and approval of their products.
Phytos offers customized, economically attractive analytical solutions and individual advisory.
As a client of Phytos you benefit from their long-term expertise in laboratory analytics. A wide range of chemical, physical and microbiological testing methods provides rapid and efficient solutions for the most demanding analytical problems.
Personal project managers and strong internal processes ensure short lead times, clear communication and high order processing efficiency. The key advantage for customers include fast processing of orders and personal and custom support at the same time.
Phytos holds a manufacturing license for analytics and approval of medicinal products as contract laboratory in accordance with ยง 13 of the 15th German AMG and is FDA inspected.