Supporting pharmaceutical companies, manufacturers, importers/distributors, individuals and healthcare organizations to meet regulatory requirements and maintain the highest quality standards.
- What We Offer
Service areas covered under this practice
Medicine, Medical Devices & Diagnostics Regulations
GMP Compliance, Quality Assurance & Audit
Local Technical Representation (LTR)
Regulatory Affairs Management (RAM)
- Regulatory Affairs
Medicine, Medical Devices, Diagnostics Regulations and Regulatory Affairs
We support clients throughout the entire product registration lifecycle, from dossier preparation to post-submission follow-up and maintenance.
Classification assessment and regulatory pathway determination.
Dossier preparation and technical documentation review this include preparation, review, submission, follow up of Dossiers and compilation of Common Technical Documents (CTD).
Submission and management of product registration applications.
Regulatory gap assessments and dossier readiness reviews.
Coordination and management of regulator queries and deficiency responses.
Follow-up and facilitation of registration processes until approval.
Product renewal and variation management.
From dossier preparation to GMP inspection readiness — every service area is built around regulatory rigour and practical delivery.
Site Master File (SMF) review and optimization.
GMP application preparation and submission.
GMP inspection readiness assessments.
Local and overseas GMP pre-inspection audits.
Corrective and Preventive Action (CAPA) development and implementation review.
Quality Management System (QMS) strengthening.
Supplier qualification and vendor audits.
Independent third-party GMP and Quality Assurance audits.
- Quality Assurance
GMP Compliance, Quality Assurance and Audit Services
Our compliance experts help manufacturers achieve and maintain Good Manufacturing Practice (GMP) standards and inspection readiness.
- Representation
Local Technical Representation (LTR)
We provide Local Technical Representative services for local and foreign manufacturers seeking to register and maintain products in Tanzania.
Regulatory representation before TMDA.
Registration support and correspondence management.
Regulatory compliance monitoring.
Renewal and variation management.
Market authorization support.
Regulatory Affairs Management (RAM)
Serving as a strategic regulatory partner, we coordinate and manage complex regulatory matters on behalf of clients, ensuring timely resolution and compliance.
- Request an Audit
Need regulatory support for a pharmaceutical or medical product challenge?
Our team is ready to support your product registration, GMP compliance, local representation, or regulatory affairs management needs across Tanzania and the broader East African region.
