Thesyl : Your Trusted Partner in Clinical Research, Regulatory Affairs & Pharmacovigilance.

A Contract Research Organisation built for Africa

THESYL is incorporated in Sweden and operates from Kigali, Rwanda - bringing together regulatory, clinical, and pharmacovigilance expertise to serve pharmaceutical manufacturers, Marketing Authorization Holders, and clinical research sponsors across Africa and globally.

How Thesyl began

Thesyl was incorporated in Sweden in 2022 - founded on the observation that Africa's pharmaceutical research and regulatory landscape required specialised, in-market expertise that existing organisations were not providing. Global pharmaceutical sponsors either bypassed Africa entirely or relied on organisations without direct in-country regulatory relationships.

Thesyl was established to operate at that intersection: global standards applied locally, with regulatory relationships, operational knowledge, and healthcare system understanding built from direct in-country engagement. Operations in Rwanda commenced in 2024 with the onboarding of Thesyl's first client - a 50-product registration programme at Rwanda FDA that remains active today.

Key facts

Incorporated

Sweden - 2022

Operations commenced

Kigali, Rwanda - 2024

Services

Regulatory Affairs - Clinical Research - Pharmacovigilance

Active registration portfolio

31 dossiers submitted at Rwanda FDA

Product categories

Generics - Biologics and Biosimilars - Nutraceuticals

Geographic scope

Rwanda operational - East Africa mapped

Rooted in Africa, aligned with global standards

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.

THESYL's operational foundation is in regulatory affairs, with an active portfolio of product registration submissions at Rwanda FDA. We are actively building capacity in clinical research operations and pharmacovigilance, with services designed to meet local and international regulatory standards.

The opportunity we are addressing

Africa carries a growing and underserved pharmaceutical research burden. Non-communicable diseases - cardiovascular disease, diabetes, cancer, COPD, and metabolic disorders - now account for the majority of premature deaths across the continent, yet African patient populations remain systematically underrepresented in global clinical trials.

What most international manufacturers do not realise is that Africa's regulatory environment is maturing rapidly. Rwanda FDA achieved WHO Maturity Level 3 in December 2024, and the African Medicines Agency, headquartered in Kigali, is building the continental architecture for joint regulatory reviews and harmonised standards.

THESYL exists to serve manufacturers, sponsors, and MAHs who understand that Africa is not a future opportunity - it is a present one. The regulatory infrastructure is in place. The patient populations are accessible. The need is urgent.

<3%

of global trials include African sites

African NRAs with WHO ML3 status

AMA

headquartered in Kigali

Why we exist

THESYL is committed to advancing health research and improving access to safe, effective medicines across Africa. We believe that African populations deserve the same standard of evidence-based healthcare as any other, and we work to enable that through rigorous clinical research, pharmacovigilance, and reliable regulatory affairs practice - applied at the quality level that global standards require.

What guides everything we do

Excellence

We are committed to delivering exceptional results and maintaining the highest standards of quality and integrity in all our endeavors.

Innovation

We embrace creativity and continuously seek new ways to improve processes, drive efficiency, and advance healthcare solutions.

Collaboration

We believe in the power of teamwork and collaboration, both internally and externally, to achieve shared goals and maximize impact.

Integrity

We conduct ourselves with honesty, transparency, and ethical integrity in all aspects of our work, earning the trust and respect of our clients, partners, and stakeholders.

Diversity and Inclusion

We celebrate unique perspectives and contributions of individuals from diverse backgrounds, fostering an inclusive culture that promotes equality and opportunity for all.

Accountability

We take responsibility for our actions and decisions, ensuring transparency, trust, and consistent delivery on our commitments.