R&D Director

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

In recent years, our company has actively introduced international professionals to form a special team to prepare for the EU GMP certification, successfully passed the EU certification on-site audit in July 2018, and successfully obtained the EU GMP certification certificate in November 2019. In September 2017, the Dutch expert Marco Albada Jelgersma was hired as the EU quality releaser. Mr. Marco is a senior pharmacist in the EU and the EU regulation consultant. Mr. Marco carefully understood the current production situation, the laboratory experiment progress, and the preparation progress of GMP documents, providing 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 is a former FDA auditor and has rich experience in GMP in the United States and the European Union, was introduced. After many communications, the expert analyzed the gap between the current situation of our company and the standards of the United States and Europe, comprehensively and systematically evaluated the preparation of GMP work, put forward the evaluation of the problems and defects in the current work, and put forward the implementation plan to improve and strengthen the GMP management in the future period, so as to promote our company to successfully pass the EU certification. In April 2018, in order to ensure the smooth passing of the official audit of the EU, LUCIANO MASCIANTONIO was specially hired to conduct a phased work audit. This audit was conducted in full accordance with the requirements of on-site inspection of GMP in Europe and the United States, recording the compliance of personnel with the implementation of GMP regulations in Europe and the United States under various dynamic conditions. At the same time, the compliance of current GMP documents and records will be checked in depth and detail by module. The expert clearly stated that at the current level, our company's software and hardware have basically met the requirements of the European Union and FDA for GMP, which has strengthened our confidence in passing the official on-site audit of the European Union at one time. In July 2018, JOANNA EWA MANIA was hired as the EU quality release agent of our company. She is a senior drug consultant in the EU. Through this consultation, we will confirm that the project has been able to meet the requirements of EU regulations, so as to meet the formal on-site audit. She went into the workshop and pointed out the existing problems and areas for improvement. In terms of product registration in Europe, we also carefully explained the requirements of EU regulations. JOANNA's work attitude of keeping improving has left a deep impression on our employees, and also reflects the severity of the drug production process in EU countries. From July 16 to 20, 2018, our company welcomed the strict and meticulous acceptance of the software and hardware system by the Portuguese official GMP prosecutor for five days. 4. The prosecutor agreed that our company's quality management system is sound and has met the inspection requirements of the EU GMP certification. In November 2019, Italian experts ANGELO CONSOLARO and BRUNO XOMPERO were introduced. The above two experts have many years of development experience in the field of blowing, filling and sealing equipment. Through many communications and exchanges, as well as on-site guidance and careful training for our company's technical personnel, in-depth and detailed inspection was carried out by modules to enable our company's technical personnel to master the operation of the equipment. The expected results have been achieved, and the equipment software and hardware have been further improved. In the future, our company will continue to implement the project of introducing talents, introduce foreign experts, guide and promote the entry of anti-tumor drugs into the international market.