Welcome to SEQ Regulatory Safety & Vigilance Services, where we offer comprehensive solutions across various industries, ensuring compliance with pharmacovigilance and safety measures.
Veterinary Pharmacovigilance Compliance: Marketing Authorization Holders (MAHs) must establish an appropriate pharmacovigilance system to assume responsibility for Veterinary Medicinal Products (VMPs) on the market. We guide you through compliance with Article 74 of Directive 2001/82/EC and Article 48 of Regulation (EC) No. 726/2004.
Cosmetovigilance for Cosmetic Products: Cosmetovigilance involves the collection, evaluation, and monitoring of undesirable events related to cosmetic products. Responsible Persons (RPs) play a crucial role in continuous monitoring and risk assessment, ensuring compliance with post-market surveillance. New regulations now mandate distributors to report serious undesirable effects in Europe to local competent authorities.
Herbal Products Pharmacovigilance Systems: Whether it’s herbal medicinal products, certain medicinal products for external use, or natural remedies, the marketing authorization holder must operate a pharmacovigilance system. We provide guidance to meet regulatory obligations.
Medical Device Adverse Incident Evaluation: Adverse incidents related to medical devices are evaluated, and information is disseminated to prevent repetition through National Competent Authority Reports (NCARs). Our established network of PV providers ensures comprehensive safety measures for medical devices.
For more information on SEQ Regulatory Safety & Vigilance Services, please contact us at enquiries@nerin.co.im.
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