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Regulatory Submission SupportNo We ensure regulatory submissions comply with EU standards to maintain product marketability.
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Document ManagementEfficient handling and organisation of all necessary regulatory documents for easy access and use.
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Product RegistrationManaging the full process of product registration with relevant authorities for market access.
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Compliance Monitoring and LiaisonOngoing monitoring of compliance and acting as liaison with EU authorities to maintain standards.
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Continuous Point of ContactWe provide ongoing representation as your main liaison with EU regulatory bodies for seamless communication.
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Post-Market Surveillance ReportingWe oversee the preparation and submission of post-market surveillance reports to meet EU requirements.
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Proactive Compliance UpdatesWe proactively update your compliance status, keeping you informed of necessary changes and requirements.
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Compliance AssessmentThe onboarding process starts with a detailed compliance assessment to ensure all requirements are met.
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Registration with EU AuthoritiesFinally, registration with relevant EU authorities initiates official representation.
