Regulatory Affairs

Regulatory expertise built for Africa

THESYL provides regulatory affairs services for pharmaceutical manufacturers and Marketing Authorization Holders entering and operating across African markets. We manage product registration, regulatory strategy, dossier compilation, and regulatory intelligence — supported by an RMS — applying ICH-standard methodology within the frameworks that govern Africa's rapidly evolving regulatory landscape, from national authorities to continental harmonisation bodies.

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Geographic Scope

Rwanda - Operational

Active registration portfolio at Rwanda FDA. 31 dossiers submitted, 1 MA received.

Active

Africa - Expanding

Requirements mapped across Uganda, Kenya, Tanzania, Burundi, and DRC.

Expanding

Africa and Beyond - Long-term

Continental Africa and global markets as THESYL's practice grows.

Long-term

31

Registration Submissions

Rwanda FDA as of June 2025

3

Product Categories

Generics, Biologics/Biosimilars, Nutraceuticals

6

African Markets

1 active, 5 under regulatory mapping

Our Approach

Our Regulatory Approach

Principles That Guide Our Work

Patient-centered

A patient-centered approach ensures that all our decisions and actions prioritize patient safety and the accessibility of healthcare products. This involves understanding patient needs, maintaining product safety through compliance, and aligning regulatory strategies to drive better patient health outcomes.

Collaborative

We are inherently collaborative, requiring ongoing communication with multiple stakeholders, including health authorities, clients, partners, and internal teams. Our collaborative approach guarantees that all parties work toward the specific regulatory goal of securing approval while maintaining high-quality standards.

Tailored solutions

We develop tailored solutions by customizing strategies to meet the unique regulatory requirements of each market, product, and client. This approach addresses the specific challenges presented by different therapies, countries, and regulatory environments, ensuring compliance and facilitating efficient regulatory approvals.

Data-driven

Our decision-making process is data-driven, integrating scientific, clinical, regulatory, and market data to support the approval process. By leveraging advanced analytics and generating actionable insights, our regulatory affairs team enhances submission strategies, ensures ongoing compliance, and drives continuous improvement across the product lifecycle.

What Sets Us Apart

In-country depth

Our understanding of the countries we operate in — their regulatory frameworks, authority relationships, and review processes — gives clients access to the insight that makes the difference between a stalled submission and a successful one.

ICH standards throughout

Every dossier we prepare meets the same scientific and documentation standards expected by any stringent regulatory authority — regardless of the market.

Intelligence-led strategy

We make decisions based on how the regulatory environment works today — not how it was documented two years ago. Our active monitoring of African NRAs, harmonisation bodies, and authority developments feeds directly into every submission strategy we build.

Built to scale

We structure every engagement to grow with the client — starting with a single market or product and expanding across markets, therapeutic areas, and service lines as the programme develops. THESYL's RMS supports this scalability — tracking active dossiers, managing submission timelines, and reporting progress across multi-market programmes.

Service 01

Product Registration - Marketing Authorisation

THESYL manages registration on behalf of MAHs across African markets including pre-submission planning, dossier gap analysis, authority submission, and post-registration maintenance.

Registration Pathways

01

Full Assessment Pathway

Comprehensive quality, safety, and efficacy review for complex products.

02

Recognition/Reliance Pathway

Leverages prior SRA or WHO assessments to shorten timelines.

03

Abridged Assessment Pathway

Focused review for generics emphasizing quality and BE evidence.

What we manage

  • Regulatory strategy and pathway selection
  • Submission plan and timeline management
  • Dossier gap analysis against NRA requirements
  • Portal submissions including iRIMS for Rwanda FDA
  • Query management, variations, and renewals

Markets covered

Rwanda

Rwanda FDA

Active

Uganda

NDA Uganda

Mapped

Kenya

PPB/KEBS

Mapped

Tanzania

TMDA

Mapped

Burundi

ABREMA

Mapped

DRC

ACOREP

Mapped

Service 02

Regulatory Affairs in Clinical Trials

Clinical trial initiation in Africa requires coordinated regulatory submissions across multiple bodies — the regulatory authority and the ethics committee. THESYL manages the full regulatory submission track for clinical trials, from initial document compilation through to authority approval and ongoing compliance during the conduct of the study.

In Rwanda, clinical trials require submissions to Rwanda FDA as the competent authority and the national ethics committee. Both tracks are managed — coordinating documentation, responding to queries, and maintaining timelines across review processes.
  • Regulatory document preparation and verification
  • Submissions to ethics committees and competent authorities
  • Country-specific CTA submissions and follow-up
  • Protocol amendments and DSUR submissions

Service 03

Regulatory Intelligence

Requirements are evolving rapidly. THESYL tracks NRA updates, continental harmonisation initiatives, and operational authority practices to inform submission strategy and lifecycle compliance.

  • Rwanda FDA process and guideline monitoring
  • Landscape monitoring across Uganda, Kenya, Tanzania, Burundi, and DRC
  • AMA, AMRH, EAC, and ZAZIBONA developments
  • Multi-country strategy and annual intelligence reporting

Service 04

Technical and Scientific Writing

We produce high-quality regulatory and safety documents aligned to ICH CTD structure and African authority requirements.

  • CTD compilation (Modules 1-5)
  • Study protocols and amendments
  • IBs, ICFs, DSURs, PSURs, PBRERs, PADERs, and CSRs
  • Scientific manuscripts and publications

African Regulatory Harmonisation

Africa's regulatory landscape is converging. We track the harmonisation frameworks already affecting submission strategy and those shaping the next five years.

AMA

Continental harmonisation and joint review framework.

AMRH

Regulatory convergence across AU member states.

EAC

Joint assessment framework across member NRAs.

ZAZIBONA

Mutual recognition-driven acceleration pathway.

Entering an African market? Let us assess the pathway.

Whether you need a single-market strategy or a multi-country programme, we assess your product, dossier readiness, and applicable pathways to define clear requirements and realistic timelines.

Request a regulatory assessment