in terms of Regulatory Affairs
Relying upon a twenty years’ experience in the involved markets and upon skilled Regulatory Affairs Specialists, amitahc can provide a valid support for technical and legislative matters to the partners. The RA team is constantly attentive to any updating concerning safety, quality and environment and checks their correct application both in ingredients and finished products sharing information with the commercial staff and giving a precious consulting service to anyone who needs it. amitahc is an active member of the main European Trade Associations taking part in regulatory working groups.
The RA Dpt collects, checks and releases the whole technical documentation concerning the ingredients marketed by amitahc (Product Specification, Certificate of Analysis, Safety Data Sheet, Declarations, Safety/Efficacy Tests and Clinical Trials) creating a real Product Dossier available for any partner. In case of particular requests for additional technical documentation or information on ingredients or in case of specific technical-regulatory questions, the RA Dpt contacts the producer partners, the Trade Associations and the Authorities promptly to receive, when possible, specific documents and answers in order to fullfil the partners’ requests.
In line with the globalization of the markets and the requirements of our partners who are approaching them, the RA Dpt checks priorly that the ingredients in portfolio comply with the main international involved markets and elaborates the the technical documentation accordingly, keeping informed and updated about the evolution of the markets and of the international standards of safety and quality.