Multinational IVD Compliance: Scalable Regulatory Intelligence for Multi-Country Submissions
- Abstract
- Problem Statement:
Explore how a strategic approach to Regulatory and Market Intelligence enabled a client to gain in-depth insights into the pharmaceutical landscape across seven Sub-Saharan African countries. Faced with the challenge of understanding complex regulatory processes, competitor dynamics, and market distribution policies in Kenya, Ghana, Tanzania, Zambia, Angola, Nigeria, and South Africa, the client turned to Freyr GRI for comprehensive Regulatory Intelligence support.
- The client needed a streamlined process to gather regulatory and market intelligence for pharmaceuticals across seven Sub-Saharan African countries.
- There was a lack of standardized templates for developing country-specific regulatory and market intelligence reports in the region.
- Identifying relevant information on regulatory processes, competitor companies, products, and pricing presented significant challenges.
- The client required detailed insights into market distribution policies to make informed strategic decisions.