Quality Assurance (QA) and Regulatory Affairs (RA)

Quality Assurance (QA)

Our services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our associates are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

We facilitate in the following areas

• Quality System Automation Using Software
• Quality Systems Implementation
• Quality System Remediation / Improvement
• Risk Management ICH Q9 – We can provide you with the staff and tools needed to implement or remediate your quality systems to current industry standards and train your personnel to manage it.
• Corrective and Preventive Action (CAPA) and Complaint Systems – We manage implementation and remediation of CAPA systems and Complaint Handling Systems.
• 21 CFR Part 210 and 211
• EU Good Manufacturing Practice (GMP)
• Guidelines
• Computerized System Validation Standard Operating Procedure (SOP) – Our computer validation experts and software engineers have extensive experience with the GAMP5 validation model to ensure that you have the appropriate level of documentation.

Laboratory Support

• SOP Development
• Method Transfer
• Method Validation

Regulatory Affairs (RA)

We facilitate our client journey in every step from Plant to Product approval and registration domestically (East Africa PPB Kenya, NDA Uganda , MOH Rwanda and TFDA Tanzania) and Globally (through our associate) .

We facilitate in the registration of products (All formulations for Human products and Veterinary products) [including conventional products, vaccines and biological products, medical devices, Supplements, Herbal products also for radiopharmaceuticals)