Sardius Pharma Limited is a company established in 2022 in Nairobi, Kenya to provide Pharmaceutical Regulatory Services, Local Technical Representation (LTR), Pharmacovigilance, Quality Assurance, Clinical Trial Registration and Support, Compliance, Training, Market Research, Intelligence, Policy and advocacy and Governance among other services.
Making a positive impact to our client’s patients through our technical know how, reach and passion.
To be the leading Biopharmaceutical Regulatory and allied service provider in Sub Saharan Africa, ensuring access to quality healthcare products.
Health Products and technologies with expertise in Vaccines and biologicals, Medical Devices and IVDs, Pharmaceutical Products, Borderline products, Cosmetics, Blood and Blood Products and Consumer products
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.
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. The diverse team provides specialized expertise from Kenya, Francophone West and Central Africa (FWCA) region, Eastern Africa, Anglophone West Africa (OWA) and Southern Africa collaborating with experienced network of Regulatory professionals across the region
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.