Sardius Pharma Limited aims to help pharmaceutical companies succeed in Africa by providing multi-market Regulatory Services support in the highly complex Africa markets using a wealth of regulatory affairs experts within the team.
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The team has a vast experience in New Product Registrations and Marketing Authorizations, license Maintenance, Post approval Changes, Divestments, Portfolio Optimization, Renewals, Labelling, Artwork Management, Samples Management, Translations,, Clinical Trial Registration, Local Technical Representation (LTR), Policy and Advocacy, Regulatory Intelligence, legislations and guideline impact assessment.
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The Sardius Pharma team combined has over 35 years of experience in working with health regulatory agencies/oversight bodies across Africa to deliver and ensure highest level of regulatory compliance is observed in line with local regulations.
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We are able to provide a wide range of Pharmacovigilance services, QPPV, Medical Affairs, Risk management and Analysis and relieve you the burden of reporting and management of Human safety Information (HSI).
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We are experts in Quality assurance, Good Distribution Practices and we can provide you with bespoke solutions to all your Quality needs
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We provide in-depth training and insights to your business on Ethical practices, Compliance and Business Integrity aligned with Industry Best practice and standards to help your business operate in a sustainable and ethical way.
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We are a regulatory service provider who can provide these services in serveral markets in Sub-Saharan Africa.