Identifying current global regulations for foods and supplements (concentrated sources of nutrients or other substances with a nutritional or physiological effect), including current ingredient approvals, labeling requirements, use of health claims, food contact materials, and clinical trial requirements.
Designing regulatory strategies to meet international requirements and pre-empt regulatory concerns in one or multiple jurisdictions.
Preparing submissions, from pre-meeting packages, complete dossiers for new active substances, to post-marketing changes for regulatory agencies worldwide.
Liaising with regulatory agencies, including facilitating meetings and providing independent, third-party critical advice on and responses to regulatory issues.
Developing global regulatory monitoring programs to ensure that products remain compliant in changing regulatory climates.
We manage everything the food supplements registration for you
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European market access support services | Azierta
Azierta provides support in European Market access to medicines and medical devices, existing or authorised by the AMPS.
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