Bloom Technologies

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 a given 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 will provide 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 can prepare and support 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

03

National Pharmaceutical Manufacturing Policy Design

Following the pharmaceutical manufacturing plan for Africa, our team can work 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.
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04

Quality Gap Assessments & Research

Using evidence-based methodologies, our team can support you in the design of various relevant quality gap research as a diagnostic tool to identifying systemic deficiency to enable risk-based intervention for improvement of quality systems.

Impact Stories

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