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 applying ICH-standard methodology within Africa's evolving regulatory landscape.

Request a regulatory assessment

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

We prioritize patient safety and healthcare product accessibility in every regulatory decision.

Collaborative

We coordinate closely with authorities, clients, and internal teams to secure approvals efficiently.

Tailored solutions

Strategies are adapted to each product, market, and regulatory environment.

Data-driven

Scientific, clinical, and market data shape better submissions and ongoing compliance.

What Sets Us Apart

In-country depth

Direct understanding of national review processes and authority expectations.

ICH standards throughout

Dossiers meet international quality standards regardless of target market.

Intelligence-led strategy

Strategy is built on current authority behavior and active regulatory monitoring.

Built to scale

Engagements scale from one market to multi-market programmes with RMS support.

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 requires coordinated submissions to competent authorities and ethics committees, often in parallel. THESYL manages both tracks from startup through lifecycle compliance.

In Rwanda, trial submissions run in parallel to Rwanda FDA and Rwanda National Ethics Committee (RNEC), with synchronized document control and query handling.
  • 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