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TMDA Regulatory Affairs
We provide comprehensive consultancy and advisory services to individuals, companies and institutions on matters relating to the Tanzania Medicines and Medical Devices Authority (TMDA).
Registration, licensing and trade
Consultancy and advice on all TMDA regulations, standards and requirements.
Registration and licensing for importation, exportation and distribution of medicines, medical devices and diagnostics.
Dossiers and applications: preparation and submission of all documents TMDA requires.
Premise registration: warehouses, retail shops and manufacturing plants must be inspected and registered.
Compliance and quality
Health product compliance: advice on quality, safety and efficacy standards.
GMP compliance advisory: guidance on Good Manufacturing Practice and certification readiness.
Quality audits: independent audits against TMDA and international standards.
CAPA management: develop and monitor Corrective and Preventive Actions to close gaps.
QA/QC systems strengthening: set up and improve Quality Assurance and Quality Control frameworks.
Training and capacity building
Staff and management training on TMDA regulatory compliance.
After registration and studies
Post-registration support and guidance on pharmacovigilance and adverse event reporting.
In-country performance studies and clinical trials: support in designing, conducting and documenting local studies to meet TMDA requirements.
TBS Supplement Registration
Ten steps, from your first question to a certificate in your hand.
Prepare
- Product classification and regulatory assessment
- Review of product formulation and ingredients
- Review and correction of product labels
- Review of COA, MSDS, GMP and other technical documents
Submit
- Preparation of the TBS application and dossier
- Submission and follow-up with TBS
- Handling and responding to TBS queries and requested amendments
- Coordination of product sampling and testing if required
Certify
- Assistance until the TBS Product Registration Certificate is issued
- Post-registration support and renewal
Ready to Navigate Tanzania's Regulatory Landscape?
From TMDA to TBS — we guide you every step of the way.
Book a Free ConsultationCall 0718652219