| Company profile | We, at SLS Europe, bring your product development to life.
With our expert team, we offer tailored services for swift and successful pharmaceutical product launches. Our expertise includes regulatory consultancy, product development, and marketing authorization support. As your trusted partner, we can act as your marketing authorization holder in Europe, managing all aspects of the application process efficiently. Our services also include pharmacovigilance support, along with import and release procedures, guaranteeing compliance and smooth integration into the European market.
Since 2002, we have guided clients through the development of pharmaceutical candidates, from R&D to market launch. Our long-standing experience and industry network in Europe and beyond enable you to bring your projects into market faster, more cost-effectively and with a higher probability of success.
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| Products & Services | – Marketing Authorisation Holder (Sponsor)
– Clinical Trial Management and Oversight (Sponsor)
– Regulatory and Strategic Consultancy
– Translational Project Management
– Quality Management System Development
– Due Diligence
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| References and export activities | – Marketing authorisation application of COVID-19 and TB diagnostics in Europe
– Licensure of R21/Matrix-M Malaria vaccine in Ghana
– WHO prequalification of R21/Matrix-M Malaria vaccine
– Fast-track designation of ANTIBKV monoclonal antibody by US FDA
– Development of the frontrunner TB vaccine VPM1002
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| Target group | – Pharmaceutical Companies
– Biotechnology Companies
– Start-ups
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| Competitive advantages | – Marketing authorisation activities including application and holder (Sponsor)
– Subsidiary of the world’s largest vaccine manufacturer (Serum Institute of India)
– Coordination of import, release and storage of pharmaceuticals
– Regulatory affairs with European and global agencies
– Clinical trial management
– Sponsor in clinical trials
– Product development
– Establishment of quality management system
– Medical expertise
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| Ideal Business Partners | – Companies with existing pharmaceutical products who aim to bring their products to Europe, India and Africa
– Biotech companies who aim to expand their development projects to Europe, USA, India and Africa
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