Pharmaceutical Quality Systems
Pharmaceutical Quality Systems & Manufacturing Excellence
Bloom delivers world-class pharmaceutical systems strengthening to support manufacturers, regulators, and governments in meeting international pharmaceutical standards and improving medicine quality across Africa.
Key Services
What we offer
01
National Medicines Regulatory System Strengthening
For any supply chain to resist the introduction of substandard or falsified medicines, the national regulatory system of that country needs to be strengthened. The quality of medicines in each country is directly related to the stringency of its national medicines’ regulatory authority. At Bloom we work with countries to establish a strategic plan and roadmap for the migration of the authority to a high level of WHO Global Benchmarking tool category. Our team provides support in almost all regulatory functions including quality control lab, registration, inspection, post market surveillance, Pharmacovigilance, etc.
02
Manufacturing Quality Support
Many manufacturers in Africa are still excluded from the large procurement for public health programs on the continent. Our team prepares and supports individual companies on their way towards internationally acceptable quality to make them eligible to participate in various tenders for public health medicines in Africa. We guide manufacturers through the journey toward global competitiveness, including:
1. GMP compliance
2. WHO prequalification pathways
3. Facility upgrades
4. Quality control systems
1. GMP compliance
2. WHO prequalification pathways
3. Facility upgrades
4. Quality control systems
03
National Pharmaceutical Manufacturing Policy Design
Following the pharmaceutical manufacturing plan for Africa, our team works with different governments to identify how to adapt and adopt the plan to their country specific needs, as well as craft a roadmap and provide technical assistance to the country and individual manufacturers to attain and participate in the continental manufacturing plan.
Inflow this week is up
Compared to the last week
04
Quality Gap Assessments & Research
Using evidence-based methodologies, our team supports the design of various relevant quality gap research as a diagnostic tool to identify systemic deficiencies to enable risk-based intervention for improvement of quality systems.
Impact Stories
