About Us
Quality Management and Regulatory Compliance
Design Controls and FDA Submissions for De Novos, 510 (k) clearance and EUA
Design Controls and FDA Submissions for De Novos, 510 (k) clearance and EUA
- Our Quality Expert, Dr. Jaspreet A. Seth PhD, Chief Operating Officer, is a results-driven professional with extensive experience in quality management systems and regulatory compliance in the life sciences and medical devices industries.
- Dr. Seth's core competencies include ensuring compliance with ISO 13485, ISO 9001, and cGMP regulatio
- Our Quality Expert, Dr. Jaspreet A. Seth PhD, Chief Operating Officer, is a results-driven professional with extensive experience in quality management systems and regulatory compliance in the life sciences and medical devices industries.
- Dr. Seth's core competencies include ensuring compliance with ISO 13485, ISO 9001, and cGMP regulations, implementing CAPA, conducting internal audits, and managing change control processes.
- Dr. Seth is adept at interpreting complex regulatory requirements, driving quality improvement projects, and fostering a culture of excellence.
- With a proven track record in hosting successful audits and managing FDA submissions, Dr. Seth ensures that your product meets and exceeds regulatory standards.
Design Controls and FDA Submissions for De Novos, 510 (k) clearance and EUA
Design Controls and FDA Submissions for De Novos, 510 (k) clearance and EUA
Design Controls and FDA Submissions for De Novos, 510 (k) clearance and EUA
- Our Chief Scientific Officer, Dr. Srilekha Deka, MD, PhD, is an accomplished biotechnology professional with extensive experience in commercializing diagnostic assays in highly regulated industries.
- She is a proactive leader with a strong track record in managing multiple projects, developing innovative products, and ensuring compliance
- Our Chief Scientific Officer, Dr. Srilekha Deka, MD, PhD, is an accomplished biotechnology professional with extensive experience in commercializing diagnostic assays in highly regulated industries.
- She is a proactive leader with a strong track record in managing multiple projects, developing innovative products, and ensuring compliance with regulatory and quality standards.
- Her expertise spans product development, regulatory submissions, quality management, and clinical trials, making her a valuable asset in bringing biotech innovations to market.
Strategic Marketing
Design Controls and FDA Submissions for De Novos, 510 (k) clearance and EUA
Strategic Marketing
- Our Marketing Expert, Dr. Krishnan Allampallam, PhD, MBA, excels in developing global marketing strategies and leading multifunctional teams in the IVD, oncology, and infectious disease markets.
- Having launched multiple products in the life sciences and IVD markets, he brings a deep understanding of various technologies, including next-ge
- Our Marketing Expert, Dr. Krishnan Allampallam, PhD, MBA, excels in developing global marketing strategies and leading multifunctional teams in the IVD, oncology, and infectious disease markets.
- Having launched multiple products in the life sciences and IVD markets, he brings a deep understanding of various technologies, including next-generation sequencing (NGS).
- His expertise in oncology is backed by multiple publications, making him an invaluable asset in navigating complex product launches and market entry strategies.