Bio Preventive Medicine Corporation (BPM) is a leading biotech company specialising in renal biomarkers. With a focus on translating validated and IP-protected novel biomarkers into diagnostic solutions for unmet clinical needs, BPM has developed innovative products that are revolutionising the field of kidney disease diagnosis and management.
One such product is the DNlite-IVD103, a non-invasive ELISA-based prognosis test that predicts renal function loss years in advance. Andaman Medical, an independent licence holder for BPM in Vietnam and Indonesia, has played a crucial role in the company’s expansion into these markets. With regulatory expertise and experience in the region, Andaman Medical has facilitated the registration and market authorization of BPM’s products, including DNlite-DKD uPTM-FetA ELISA kit (DNlite-IVD103).
ASEAN is an important market for BPM’s products, particularly DNlite-IVD103. With a large and growing population, Vietnam and Indonesia offer significant opportunities for the company to expand its business and contribute to the region’s healthcare landscape.
Background and Challenges
Global biomedical companies always face regional challenges in expanding its products into new markets, and need reliable partners with local knowledge and regulatory expertise to navigate the complex regulatory landscape and ensure compliance with local requirements. Andaman Medical, with its extensive experience in the region, was the ideal partner to help BPM achieve its goals.
Solution Evaluation
Andaman Medical’s regulatory expertise and market knowledge were key factors in BPM’s decision to choose the company as its partner. Andaman Medical’s ability to navigate the local regulatory environment efficiently and effectively was critical in securing market authorisation for BPM’s products.
The implementation process was smooth and successful, with no specific difficulties encountered. Andaman Medical’s consultants were knowledgeable about the local requirements and responsive to BPM’s questions, ensuring a seamless collaboration.
Results and Benefits
The partnership between BPM and Andaman Medical has yielded important results. The device performance data that BPM provided in the prognosis of kidney function for type-2 diabetic patients were very solid, and with the regulatory expertise from Andaman, DNlite-IVD103 received registration licences from the Ministry of Health in both Vietnam and Indonesia. This milestone marks an important achievement for BPM and Andaman Medical, as it paves the way for the company to expand its footprint in these markets. The product’s ability to predict renal function loss years in advance makes it an invaluable tool for healthcare professionals in managing type 2 diabetic related kidney disease.
This achievement has opened new business opportunities for BPM and has positioned the company as a leader in the renal biomarker market.
Customer Experience
BPM regards their experience working with Andaman Medical as very positive. Among their comments were that the consultants at Andaman Medical were knowledgeable about the local requirements and responsive to BPM’s questions, making the entire process smooth and efficient.
The entire experience, from contract negotiation to project completion, was very smooth and positive, and Andaman Medical’s expertise was invaluable in securing market authorisation for BPM’s products.
Conclusion
The partnership between Bio Preventive Medicine Corporation and Andaman Medical has been very successful. Andaman Medical’s regulatory expertise and market knowledge have been instrumental in securing market authorisation for BPM’s products in Vietnam and Indonesia. As BPM continues to expand its business globally, Andaman Medical will assist with its expertise to navigate the complex regulatory landscape and ensure compliance with local requirements.