We navigate the complexities of Moldovan healthcare regulations to ensure your products reach the market swiftly and remain fully compliant throughout their lifecycle.
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Local Applicant & Representation: We act as your authorized local representative, managing all communications with the AMDM (Agency for Medicines and Medical Devices) and ANSA (National Food Safety Agency).
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Dossier Management (CTD Format): Expert preparation and submission of registration dossiers in accordance with national requirements and EU-aligned standards.
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Product Classification: Precise categorization of your portfolio (Medicines, Food Supplements, or Medical Devices) to optimize the registration pathway and tax obligations.
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Certification & Quality Control: Managing batch-by-batch certification and laboratory testing to ensure every product meets safety benchmarks.
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Post-Market Support: We provide ongoing pharmacovigilance, license renewals, and management of variations to keep your products on the shelf without interruption.
