SAN DIEGO and SHANGHAI, April 23, 2021 – BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, announced today its Analytical Laboratory in Shanghai Galileo Road underwent and successfully passed a Qualified Person Audit from the European Union (EU QP Audit). This achievement demonstrates the company’s ability to provide clinical product analytical services to customers undergoing clinical trials in the UK and EU markets, and also demonstrates the company’s quality system fully meets EMA, NMPA, and FDA drug regulatory requirements.
Due to COVID-19, the audit was conducted through remote review. This audit was conducted in two parts——remote documentation review and virtual tour of the relevant areas of the laboratory facilities. Documentation review included: data/document review, risk assessment, quality management system, and key laboratory processes. EU QP Auditors conducted interviews and discussions on key operational documentation and information with subject matter experts through online meetings. The BioDuro-Sundia team made adequate preparation and communicated fluently, which helped the audit to be completed smoothly.
“This successful EU QP audit adds to our successful audit history, and once again proves our high standards and efficient customer service quality,” said Haijun Dong, PhD, Global CEO, BioDuro-Sundia. “We will continue to strengthen our quality management system, helping our pharmaceutical partners to reduce the cost of new drug R&D and accelerate development milestones. We look forward to a strong future, supporting partners through our comprehensive discovery, development and manufacturing services, which of course will help bring new medicines to patients in need.”
“This past year, COVID restrictions have made audits very challenging, but thanks to the hard work of our team and auditors, we were able to accomplish this important goal,” said Hui Yu, Head of Analytical at BioDuro Sundia’s Shanghai site. “Audits are a critical part of our quality system, especially as we support later stage development and regulatory submissions—a key part of our one-stop-shop CRDMO services, from discovery through development and manufacturing.”
Since its establishment, BioDuro-Sundia has successfully passed high-quality on-site audits from regulatory agencies like the FDA and NMPA, Top 20 pharmaceutical companies, and third-party audits from North America, Europe, and the Asia-Pacific region. The company has helped more than 50 customers to successfully submit IND filings.
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and10 global sites.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.
BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.
For more information, visit: www.bioduro-sundia.com
About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.
For more information, visit: www.adventinternational.com
About Bridgewest Business Group
Founded in 1999, The Bridgewest Business Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group’s private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.
For more information, visit: www.bridgewestgroup.com