We conduct clinical trials across various therapeutic areas and phases, upholding the highest standards of efficiency, ethical integrity, and excellence in clinical research throughout Africa.
We offer robust pharmacovigilance systems to rigorously monitor the safety profiles of medical products.
We streamline the regulatory processes across African countries, providing comprehensive support to ensure compliance and smooth project execution.
31
Rwanda FDA · as of June 2025
3
Generics · Biologics & Biosimilars · Nutraceuticals
6
1 Active · 5 Under Regulatory Mapping
THESYL is a Contract Research Organization (CRO) providing effective and functional Clinical Research, Pharmacovigilance, and Regulatory services across Africa. Our company is rooted in a mission to advance health research by facilitating the development and delivery of safe and effective life-saving medicines and therapies that address the unique healthcare challenges of the African continent.
While we support research across all therapeutic areas, including infectious diseases, THESYL places particular focus on non-communicable diseases - an area of growing burden across Africa that remains underrepresented in global clinical evidence.
We conduct and manage clinical trials across all phases through conventional, hybrid, and decentralized models to ensure flexibility, efficiency, and patient-centered engagement. Our primary focus is on non-communicable diseases (NCDs), including cardiovascular diseases, diabetes, cancer, chronic obstructive pulmonary disease (COPD), and disorders affecting endocrine, hematologic, and immune systems.
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We support Marketing Authorization Holders in managing product safety through proactive risk management, advanced digital pharmacovigilance (PV) solutions, and robust regulatory expertise. Our approach ensures patient safety while maintaining full compliance with both local and international regulatory standards.
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We provide comprehensive support across all phases, from clinical trial initiation to product registration and reimbursement. Our patient-centered, tailored regulatory solutions streamline approval processes, ensure adherence to local and international requirements, and help bring safe and effective therapies to market efficiently.
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THESYL brings together regulatory, clinical, and pharmacovigilance expertise - combining direct engagement with NRAs, ICH-standard methodology, and the operational capacity to manage complex, multi-product programmes across African markets.
By leveraging our deep understanding of local healthcare ecosystems and global best practices, we deliver high-quality, efficient, and cost-effective solutions tailored to the unique needs of our clients and partners.
Our collaborative approach fosters strong partnerships with stakeholders across the healthcare industry, enabling us to accelerate the development of life-saving therapies.
Our team brings extensive knowledge and experience in clinical research, pharmacovigilance, and regulatory affairs, ensuring that your project is in capable hands.
We provide end-to-end support throughout the clinical development process, from study design and site selection to data management and regulatory submission.
Patient safety is at the core of everything we do. Our rigorous safety monitoring systems and protocols ensure that patient well-being is prioritized at every stage.
Our regulatory experts guide you through the complexities of compliance, helping you achieve approvals efficiently and effectively across multiple markets.
We develop customized strategies to meet your unique research and regulatory needs, ensuring optimal outcomes for your projects.
We leverage cutting-edge technology to enhance our services, providing you with the most advanced and efficient solutions available.
"We have been collaborating with THESYL on drug market registration projects, and their expertise has been instrumental in navigating every step. Their regulatory services have proven essential, and we look forward to expanding our partnership to include upcoming pharmacovigilance initiatives."
Placide Sophroni UWINGENEYE
Managing Director, USOPHARMA Ltd
14 March 2026
The Rwanda Food and Drugs Authority granted marketing authorization for USOPENTIN 300 - the first product to receive full Rwanda FDA registration under THESYL's regulatory management.
Read moreResearch Article
International manufacturers consistently make the same avoidable mistakes when preparing their first African submission. Here is what actually delays approvals.
Read moreAnnual Report · 2025
A comprehensive summary of material regulatory developments at Rwanda FDA in 2025 - from WHO Maturity Level 3 through new guidelines, fee structures, and submission infrastructure changes.
Read moreWhether you are entering a new African market, running a bioavailability or bioequivalence study, appointing a qualified pharmacovigilance person, or seeking regulatory support for your product portfolio - THESYL provides the regulatory affairs, clinical research, and pharmacovigilance expertise to support your programme.