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Get your product to market with confidence through expert Regulatory Affairs support. From strategy to product approval, we offer tailored services to navigate complex requirements.
Regulatory Affairs
Quality Assurance
Development and implementation of Quality Management Systems (QMS) aligned with ISO 13485, WHO GMP, and other international standards.
Qualification & Validation
We ensure your products meet quality standards and regulatory requirements by qualifying and validating your equipment, facilities, and processes.
Clinical
Assistance in designing, managing, and monitoring clinical trials within Tanzania, ensuring ethical compliance with TMDA and National Institute for Medical Research (NIMR) requirements.
OUR SERVICES TABLE
| Regulatory Affairs | Medical Devices | In Vitro Diagnostics |
|---|---|---|
| Scientific Advice | ✓ | ✓ |
| Regulatory Procedures | ✓ | ✓ |
| Submissions | ✓ | ✓ |
| Linguistic Services | ✓ | ✓ |
| RA Strategy for MD & IVD | ✓ | ✓ |
| Product Development / Design and development | ✓ | ✓ |
| Technical Documentation | ✓ | ✓ |
| Notified Body Submissions | ✓ | ✓ |
| Liaison with the notified bodies | ✓ | ✓ |
| Lifecycle management / PMS | ✓ | ✓ |
| Person Responsible for Regulatory Compliance (PRRC) for IVD | ✓ | ✓ |
| Authorised Representative Services | ✓ | ✓ |
| Companion diagnostics (CDx) | ✓ | ✓ |
| Quality Assurance | ||
| QMS Setup | ✓ | ✓ |
| QMS Remediation & Support | ✓ | ✓ |
| Qualified Person (QP) & Responsible Person (RP) | ✓ | ✓ |
| Annual Product Review (APR) & Product Quality Review (PQR) | ✓ | ✓ |
| Audits & Remediation | ✓ | ✓ |
| Outsourced QA | ✓ | ✓ |
Clinical
| Clinical Study Operations | Medical Devices | In Vitro Diagnostics |
|---|---|---|
| Clinical Study Operations | ✓ | ✓ |
| Data Management and Analysis | ✓ | ✓ |
| Clinical Safety Management | ✓ | ✓ |
| Clinical Regulatory | ✓ | ✓ |
| Clinical Quality | ✓ | ✓ |
| IVD CRO | ✓ | ✓ |
| PMCF/PMPF | ✓ | ✓ |
| Medical Writing for MD | ✓ | ✓ |
| Medical Writing for IVD | ✓ | ✓ |
| Clinical Strategy Support | ✓ | ✓ |
| Clinical Study Design Report | ✓ | ✓ |
| Clinical Expert Services | ✓ | ✓ |
Get in Touch
We'd love to hear from you. Send us a message and we'll respond as soon as possible.
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Contact Information
Labmark Limited
Josam House, Block B, Office 1
Plot 16, Mikocheni Area
Dar es Salaam, Tanzania
Josam House, Block B, Office 1
Plot 16, Mikocheni Area
Dar es Salaam, Tanzania
info@labmarkdx.com
+255679275696