Sustchem S.A.
Categories
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Country/Region:Greece
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On CPHI since:2022
Products from Sustchem S.A. (3)
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Product Medical devices - Regulatory Services
- MDR &IVDR CE certification - Data Gap analysis - Technical Documentation - Clinical & Biological evaluation - Risk management (ISO 14971) - Performance evaluation - PMS Plan & Report, PMCF Plan & Report, PSUR, PMPF - Vigilance - EUDAMED - National registration services - Economic operators’ com... -
Product Medical Writing & Toxicological Reports
- PDE - OEL - Clinical and non-clinical overviews - Environmental Risk Assessment -
Product Pharma Regulatory Services
- Pre- and Post- Authorization Consultancy - Marketing Authorization Applications (NAP/DCP/MRP) - Life Cycle Management (renewals, variations etc.) - Submission of regulatory – related documents to Health Authorities - e-CTD submissions
