Introduction to GMP Compliance Consulting Services

Amid the dual challenges of stricter regulation and accelerated innovation iteration in the pharmaceutical industry, GxP compliance operations and professional talent reserve have become the core competitiveness for enterprises to break through dilemmas. By taking "resource integration and complementary advantages" as its strategic fulcrum, Hippocrates, in collaboration with Kaisi Club, has launched a high-profile customized in-depth GxP training service. This service precisely targets the pain points in talent development for pharmaceutical enterprises, builds a talent cultivation system that integrates compliance and practicality, and helps enterprises seize the commanding heights of development in the fierce market competition.

Three-Dimensional Research: Crafting Enterprise-Specific Development Maps

Hippocrates and Kaisi Club have formed an interdisciplinary research team consisting of industry experts, data analysts, and senior consultants. Adopting a three-dimensional research model of "in-depth interviews + data modeling + scenario simulation", the team accurately identifies the core needs of enterprises.

• For enterprises in the critical phase of new drug R&D, the team goes deep into laboratories and project groups to analyze hidden needs such as technical bottlenecks in target screening and loopholes in cross-departmental collaboration processes.
• For enterprises in the commercialization stage, the focus is on practical demands such as the formulation of market access strategies and the professional knowledge reserve of sales teams.
  
• Combined with job competency models and enterprise strategic plans, big data analysis tools are used to generate talent competency radar charts for enterprises. Finally, a "one enterprise, one plan" customized training program is formulated to ensure 100% accurate alignment between training content and the enterprise’s business scenarios.

Led by Industry Think Tank: Building a Practical Curriculum Ecosystem

Leveraging Hippocrates’s advantages in digital services for the life health sector and Kaisi Club’s global industry resource network, the two parties have jointly established an integrated "industry-academia-research-application" mentor team. This team brings together industry leaders including former FDA reviewers, R&D executives of multinational pharmaceutical companies, and practical elites from top CROs. It deeply integrates international cutting-edge technology trends, the latest regulatory dynamics, and local practical experience to build a curriculum system covering the entire pharmaceutical industry chain:

• R&D Innovation Module: From AI drug design, IND application strategies to clinical trial design, it analyzes key technologies and management points throughout the new drug R&D process.
• Compliance Operations Module: It updates global regulatory dynamics in real time (such as the MAH system, EU MDR regulations, and China's new GMP) and provides solutions for building compliance management systems and risk prevention and control.
• Market Practice Module: Through real-case drills, it imparts core skills such as academic promotion strategies, KOL management techniques, and market access path planning.
  
• The curriculum incorporates practical cases such as the successful experience of an innovative pharmaceutical enterprise in responding to FDA on-site inspections and compliance management of cold chain logistics in vaccine enterprises, enabling trainees to master the ability to solve practical problems during learning.

Full-Scenario Learning Matrix: Meeting Diverse Training Needs

To adapt to the complex training scenarios of pharmaceutical enterprises, the two parties have built a "online + offline + hybrid" trinity full-scenario learning ecosystem:

• Immersive Offline Intensive Training: Closed training camps are held in professional training bases. Through practical drills such as simulated GMP workshop inspections, sandtable exercises for clinical trial protocol design, and scenario simulations for deviation handling, trainees’ knowledge application and problem-solving abilities are strengthened.
• Intelligent Online Platform: Relying on Singdi’s digital training system, it provides functions such as live lectures, virtual laboratories, intelligent question banks, and online Q&A, supporting 24/7 fragmented learning and breaking the constraints of time and space.
• Customized In-Enterprise Training: Expert teams provide on-site services to conduct special training for enterprises’ specific projects or departments. Examples include customized thematic courses on antibody drug CMC development for a biopharmaceutical enterprise and ISO 13485 quality management system training for medical device enterprises.
• The hybrid training model adopts a closed-loop design of "online preview - offline practical training - online consolidation", increasing learning efficiency by more than 40%.

Hippocrates’s customized GxP training service will continue to integrate digital technology, global industry resources, and professional service capabilities to provide more forward-looking and effective talent development solutions for pharmaceutical enterprises, and drive the industry toward higher quality and more compliant development.