PMC regulatory consultancy
Alidans is a leading PMC consulting firm committed to ensuring that these products are safe, effective and compliant with current regulations. Our mission is to provide technical and regulatory support to companies that produce and distribute medical and surgical devices, ensuring that they can bring high-quality products to market. Thanks to our experience and expertise in the sector, Alidans is able to offer tailor-made solutions to meet the specific needs of each customer.
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Personalized consultancy
Alidans offers a full range of customized services to meet the specific needs of each client:
• Regulatory Consulting for Medical Surgical Devices (PMC): assistance in the registration and authorization process of medical surgical devices at the Ministry of Health. We support companies in the preparation and submission of the required documentation, ensuring compliance with current decrees and regulations;
• Safety and Efficacy Assessment: in-depth analysis to ensure that your products are safe and effective, with the development of risk mitigation strategies;
• Research and Development: we support the development of new medical surgical devices, including efficacy testing and technical support. We ensure that new active ingredients are subject to evaluation and approval;
• Authorization Management: support in the issuing, renewal and modification of marketing authorizations for medical surgical devices, including exceptional and provisional authorizations. We are experts in navigating the simplified procedures and exceptional authorizations provided for by the regulations;
• Regulatory Monitoring: constant updates on regulatory changes and the evaluation status of medical-surgical devices, through collaboration with ECHA and other competent authorities;
• And other tailor-made services: our service offering is constantly expanding to meet the dynamic needs of the medical device sector. We are ready to develop new customized solutions to meet the specific requests of our customers.
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