Against the backdrop of accelerated digital transformation in the pharmaceutical industry, Nantong Novast Pharmaceutical Co., Ltd. (Novast, hereinafter referred to as "Novast Pharmaceutical") has entered into in-depth cooperation with Xingdi to jointly launch the digital project of TMS (Training Management System). Recently, the project kick-off meeting was successfully held in an online format. This important milestone not only marks a crucial step for Novast Pharmaceutical in the field of digital talent development, but also lays a solid talent foundation for the company's global business layout and high-quality development.
01 Project Background
As a multinational pharmaceutical enterprise rooted in China and serving the global market, Novast Pharmaceutical has extended its business to the mainstream pharmaceutical markets of China and the United States, accumulating profound technological expertise and international recognition in the R&D and production of high-end pharmaceutical formulations. With the continuous expansion of its global business footprint, the company has raised higher requirements for employees' professional capabilities (such as sustained and controlled-release formulation technology, compliance knowledge for dual filings in China and the US) and cross-regional collaboration efficiency. However, the traditional training model can no longer meet the needs of "standardized training for global teams, targeted improvement of professional skills, and real-time updates of compliance knowledge".
The launch of this TMS digital project is a core initiative of Novast Pharmaceutical to respond to the needs of global development. By building a digital training management system, the company can not only unify training standards and synchronize progress for teams in China and the US, but also customize learning paths for different positions in R&D, production, and registration. This enables employees to quickly master professional content such as drug delivery systems and FDA/NMPA compliance requirements, ultimately supporting the business strategy of "global R&D, dual filings in China and the US, and international supply" through the advancement of talent capabilities.
02 Project Kick-off Meeting
To ensure the efficient implementation of the TMS digital project, Novast Pharmaceutical and Xingdi jointly held the "Novast Pharmaceutical TMS Digital Project Kick-off Ceremony". The meeting was conducted online, bringing together heads and project team members from relevant departments of Novast Pharmaceutical (including the Human Resources and Administration Department, Quality Management Department, R&D Department, and Production and Operations Department) and the Xingdi project team. They conducted in-depth discussions on core topics such as "standardization of global team training", "establishment of a China-US compliance knowledge system", and "design of position-compatible learning paths", clarifying project implementation milestones and collaboration mechanisms, and laying a solid foundation for the smooth progress of the project.
03 Leadership Speeches
Song Zhongdong, Novast Pharmaceutical Project Director
Director Song Zhongdong stated that since its establishment in 2005 by Dr. Zhang Guohua, Mr. Prasadraju Pinnamaraju, and their team, Novast Pharmaceutical has always regarded "talent" as the core driver supporting global development—a principle that is consistent with the company's mission of "creating reliable, high-quality pharmaceuticals for patients". "Our team members come from around the world, and our business covers China and the US. Employees need to master core technologies such as drug delivery systems while being proficient in compliance requirements of multiple regions including the FDA and NMPA. The traditional training model can no longer meet the demand for 'targeted and globalized' talent development," he noted.
When talking about the cooperation with Xingdi, he expressed high expectations: "Xingdi's professional experience in the pharmaceutical digital sector will help us build a comprehensive training system covering the entire chain of 'R&D - Production - Registration - Sales'. For example, we can push standardized operation courses to the production team of the 40,000-square-meter CGMP workshop through the system; for the team responsible for dual filings in China and the US, we can provide real-time updates on regulatory dynamics and filing key points of both countries. This will not only improve employees' learning efficiency, but also ensure that the concept of 'Quality by Design (QbD)' permeates every position through systematic training."
In conclusion, Director Song emphasized: "This is not just the implementation of a training system, but the starting point for the digital transformation of our talent development system. We hope to take this opportunity to establish a smoother collaboration model with Xingdi and explore more cooperation possibilities in areas such as talent development and organizational efficiency improvement in the future."
Chen Zhonghua, General Manager of Hippocrates Business Division
General Manager Chen first recognized Novast Pharmaceutical's achievements in the international high-end formulation sector: "From the launch of PhilithTM in the US in 2012, which marked a breakthrough in 'Made in China' for pharmaceutical formulations, to passing FDA inspections with zero 483 observations for five consecutive times, Novast Pharmaceutical has set an industry benchmark with its professionalism and quality. Our previous cooperation in the digitalization of compliance systems has allowed us to witness your company's rigorous practice of the 'Quality by Design' concept—which is highly aligned with Xingdi's philosophy of 'Technology as the Foundation, Humanity as the Core'."
He emphasized that the TMS project represents a new extension of the cooperation between the two parties: "We aim not only to build a 'functional' system, but also to create a 'user-friendly' platform that meets Novast's global needs. For instance, we will design a course library tailored to the dual compliance requirements of the FDA and NMPA, and develop professional learning modules for core technology fields such as sustained and controlled-release formulations. This will enable the system to truly serve as a catalyst for the advancement of employees' capabilities." Finally, General Manager Chen clarified the project objectives: "We will strictly adhere to the timeline, ensure delivery quality, and make this project a new benchmark for 'technology + talent' collaboration between the two parties."
04 About OwlTrust® Digital Platform
OwlTrust®, as Hippocrates's core digital platform, is developed by a team of GMP industry and digitalization experts, and strictly adheres to international and domestic standards such as GMP, cGMP, FDA 21 CFR Part 11, and relevant NMPA regulations. The TMS system customized for Nantong Novast Pharmaceutical this time is developed based on the "compliance genes" and "global adaptability" of the OwlTrust® platform. It supports multilingual learning interfaces, cross-border data synchronization, and electronic signature traceability—meeting both the FDA's requirements for traceable training records and the NMPA's compliance training management standards. Meanwhile, it recommends position-specific courses through intelligent algorithms, balancing compliance and targeted learning.
05 Introduction to Both Parties
About Novast Pharmaceutical
Founded in 2005 in Nantong, Jiangsu Province by Dr. Zhang Guohua, Mr. Prasadraju Pinnamaraju, and their technical management team, Nantong Novast Pharmaceutical Co., Ltd. (Novast) is a multinational pharmaceutical company rooted in China that independently researches, develops, produces, and supplies high-end prescription drugs for the global market. Leveraging the team's rich experience in the international pharmaceutical industry, the company has always focused on the technical research and product development of drug delivery systems and sustained/controlled-release formulations, and integrated the "Quality by Design" concept into the entire R&D and production process.
The company has built a 40,000-square-meter CGMP workshop in the Nantong Comprehensive Bonded Zone, with an annual production capacity of up to 2 billion oral tablets and 176 million oral capsules, providing stable supply for patients worldwide. In the international market, its first oral hormone product PhilithTM successfully entered the US market in 2012, achieving a breakthrough in bringing China's self-developed intellectual property formulations to the mainstream US prescription drug market. To date, the company has passed US FDA CGMP on-site inspections with zero 483 observations for five consecutive times; 5 specifications of 4 products have been designated as Reference Standards (RS) by the US FDA; it has submitted over 50 applications for high-end pharmaceutical formulations to the US FDA, with 44 different formulations approved (including 13 high-tech barrier sustained/controlled-release formulations); and nearly 40 products have successfully entered the US market.
In the domestic market, the company successfully passed the NMPA product registration on-site inspection and the Jiangsu Provincial Drug Administration's GMP on-site inspection in April 2021. Since 2021, 6 self-developed and produced high-end formulations (with dual filings in China and the US, manufactured on the same production line) have obtained NMPA registration approvals, realizing "consistent standards for China and the US, and global supply". In the future, the company will continue to focus on the development of innovative drugs and high-end formulations, serving public health and contributing to society with high-quality pharmaceuticals.
About Hippocrates
The name "Hippocrates" is derived from the transliteration of "Hippocrates", the "Father of Medicine" in ancient Greece. Upholding the original aspiration of "creating health value through technology", Hippocrates is deeply engaged in digital services for the life sciences and healthcare sector (including pharmaceuticals, medical devices, etc.). With "customer success" as its core mission, it combines cutting-edge technology with human-centric services to provide customers with digital solutions in areas such as quality compliance and talent development, helping enterprises reduce costs, increase efficiency, and enhance core competitiveness. It owns brands such as Hippocrates Health and Relson Consulting, and has served over 200 pharmaceutical enterprises to date.
