Europe & Asia Consult

E&A Consult (EAC) is an internationally and global acting company focused on:

• Consultancy and regulatory services for the Pharmaceutical-, Agrochemical-, Chemical and related industries (e.g. medical Devices/Dental Materials, Cosmetics);
• Sales and marketing activities supporting customers to find the optimal Contract Research Organization (CRO), which provides them with the most relevant support in developing his molecule in time. We provide contacts to CRO’s located in Europe and Asia all of them with OECD-GLP certificate and partly AAALAC accredited;
• Regulatory Services in Japan and Korea

E&A Consult GmbH and its partner in Japan - LunaPath LLC - provide local regulatory and consulting services in Japan and Korea;

• Japan Chemical Substance Control Law

Strategic advice including review of existing test data

Full regulatory services for:

• Low Volume Exemption Notification (supply level < than 1 t per year in Japan);
• Expanded Low Volume Exemption Notification (supply level 1 - 10 t per year per site);
• Standard Notification (supply level > than 10 t per year).

If necessary:
Consultation with Japanese competent authorities;
Complete coordination of testing at local laboratories to fulfil specific requirements in Japan;

• Japanese Industrial Safety and Health Law

Strategic advice including review of existing test data

Full regulatory services for:

• Low Volume Exemption Notification (supply level less < 0.1 t per year per site);
• Standard Notification (supply level > than 10 t per year).

If necessary:
Consultation with Japanese competent authorities;

• Korean REACH and Product Notification

Strategic Advance survey and data gap analyses;
Consultation with Korean competent authority.