Association Management & Regulatory Services  

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Regulatory Services

1. Legislation: Association Management & Regulatory Services  (AMRS) offers the possibility for chemical and pharmaceutical companies to subscribe on regular updates regarding news, trends and legislative developments in the areas of food, food additives and pharmaceuticals (European Commission, Codex Alimentarius, ICH, WHO, EMEA, EDQM etc). In addition assistance can be provided regarding complex legislative topics in food and pharma.

2. Pre-marketing dossiers: AMRS  offers regulatory advice and  assistance to companies which would like to introduce a food additive on the European market. The regulatory service includes all aspects to be taken into account  for the preparation of a  safety dossier to be submitted to the regulatory authorities. After the safety has been assessed also assistance is provided regarding smooth implementation into the legislation. A summary of  achievements can be provided upon request.

3. Specifications: AMRS  provides advice and assistance to define and/or amend purity criteria for new and existing products (food additives, pharmaceutical excipients). Scope: EU Specifications, Codex Specifications, Monographs for pharmaceutical compendia.

 

Companies with an interest in the above mentioned topics are invited to contact Evert Izeboud.

 

AMRS 2017