Meraky has a team of experts committed to offering you the highest standards of service in Pharmaceutical Regulatory Affairs within the Sub-Sahara Region.

We have over 10 years of High level Pharmaceutical Industry expertise in this region.

We have been involved in the shaping of regulatory Policies within the East Africa region in collaboration with Pharmaceutical Industry. The Team is also quite conversant with the new policies with regards to the regulation of Biologics, Biosimilars as well as Medical Devices.

The EAC Harmonization Framework is a new regulatory harmonization approach that covers the East Africa Countries, Kenya, Uganda, Tanzania, South-Sudan, Rwanda and Burundi. We have successfully launched products using this platform.

Our range of Regulatory Services cover the East Africa Region Kenya, Uganda, Tanzania, Ethiopia, Sudan, South Sudan, Rwanda and Burundi as well as the larger Sub-Sahara Africa region.

In line with Good Distribution Practices (GDP) standards ensuring compliance to the required standards of quality when it comes to handling, storage and sale of Pharmaceuticals and Healthcare Products

Activities Involved:

• GDP Compliance
• Audit Preparedness and Risk Analysis
• Deviation closure and CAPA management
• Standard Operating Procedures Development
• Product Information and Labelling
• Cold Chain mapping and maintenance
• Product Recall Management
• Destruction of Pharmaceutical Products
• Product Storage and Inventory Management

Harness the best Expertise in the Region on Pharmacovigilance and Post Marketing  surveillance as well as Risk Management within QPPV requirements for the region

Activities Involved:

• GCP Compliance
• Day to day Pharmacovigilance signal reporting and submission
• Risk management Strategy
• Post marketing surveillance reports
• Submission of PBRERs and PSURs
• Training and Compliance GAP assessments
• Clinical Trials management

Costs for Quality Assurance and Pharmacovigilance are project based

This is done in line with local regulation and GCP compliance standards. We seek to understand your access objectives, align you with the necessary stakeholders and approvals as well as manage your patient access programs.

We manage an end to end solution which involves patient access program set up, seeking the relevant approvals, Healthcare Provider (HCP) management, Patient access to the medicines, Adverse event (AE) Reporting as well as internal reporting on the program.

We manage an end to end solution which involves patient access program set up, seeking the relevant approvals, Healthcare Provider (HCP) management, Patient access to the medicines, Adverse event (AE) Reporting as well as internal reporting on the program.

We ensure that the patients get their medication seamlessly as well as also ensure that your reporting is well aligned to all compliance metrics and standards