R&D Director

Provide technical guidance, lead the team, conduct product development and obtain approval

In recent years, our company has actively introduced international professional talents to form a dedicated team to prepare for the EU GMP certification. We successfully passed the EU certification on-site audit in July 2018 and obtained the EU GMP certification certificate in November 2019. In September 2017, Dutch expert Marco Albada Jelgersma was hired as the EU quality auditor. Mr. Marco is a senior pharmacist and EU regulatory consultant in the EU. Mr. Marco carefully understands the current production status, laboratory experiments, GMP document writing progress, and provides technical services and professional technical guidance for the accuracy, timeliness, and completeness of our company's production, operation, and confirmation. In September 2017, Dr. Fang, an American expert who was a former FDA auditor and had extensive experience in GMP in the United States and the European Union, was introduced. After many communications, the expert conducted a gap analysis on the current situation of our company and American and European standards, comprehensively and systematically evaluated the GMP work preparation, proposed the assessment of the problems and defects in the current work, and proposed the implementation plan to improve and strengthen GMP management in the future, so as to promote our company to pass the EU certification successfully. In April 2018, in order to ensure the smooth passage of the EU official audit, LUCIANOMASSIANTONIO was hired to conduct a phased work audit. This audit was conducted in full accordance with the requirements of on-site GMP inspections in Europe and America, recording the compliance of personnel with the implementation of GMP regulations in Europe and America under various dynamic conditions. At the same time, conduct in-depth and detailed checks on the compliance of current GMP documents and records in different modules. The expert clearly stated that at the current level, our company's software and hardware have basically met the GMP requirements of the European Union and FDA, strengthening our confidence in passing the official on-site audit of the European Union at once. In July 2018, JOANNAEWAMANIA was hired as our company's EU quality auditor. She is a senior pharmaceutical consultant in the EU. Through this consulting work, we will confirm that the project meets EU regulatory requirements and welcome the formal on-site audit. She went deep into the workshop and pointed out the existing problems and areas for improvement. In terms of product registration in Europe, we also carefully explain the requirements of EU regulations. JOANNA's attitude of striving for excellence has left a deep impression on our employees and reflects the severity of the drug production process in EU countries. From July 16th to 20th, 2018, our company received a 5-day rigorous and meticulous inspection of the software and hardware systems by the Portuguese official GMP prosecutor. The four prosecutors unanimously believed that our company's quality management system was sound and had met the inspection requirements for EU GMP certification. In November 2019, Italian experts ANGELOCONSOLARO and BRUNOXOMPERO were introduced. These two experts have years of development experience in the field of blowing, filling, and sealing equipment. Through multiple communications and exchanges, as well as on-site guidance and careful training for our company's technical personnel, they conducted in-depth and detailed inspections in modules, enabling our company's technical personnel to grasp the operation of the equipment. The expected results have been achieved, and the software and hardware aspects of the device have been further improved. In the future, our company will continue to implement talent introduction projects, introduce foreign experts, guide and promote the entry of anti-tumor drug products into the international market.