Our company provides comprehensive clinical Active Pharmaceutical Ingredient (API) services and supply, focusing on supporting the clinical development stages of drugs for global pharmaceutical and biotechnology companies. Our services cover everything from process development and scale-up to the production of clinical trial APIs, ensuring product quality that meets GMP standards. We have advanced production facilities and rigorous quality control systems that allow us to flexibly meet the demands of different clinical stages. With our extensive technical expertise and reliable supply chain management, we deliver high-quality clinical APIs on time, helping to accelerate new drug development.
Process Validation and Stability Studies
: Conducting process validation and long-term stability studies for APIs that are about to enter the market, ensuring market readiness.Commercial Production Support
: We offer seamless transition capabilities from clinical stages to full-scale commercial production, ensuring continuous supply post-drug approval.Long-Term Supply Contracts
: Providing long-term API supply contracts for drugs that have successfully passed clinical trials, supporting clients’ market expansion and business growth.Project Initiation and Planning: At the start of a project, we work closely with clients to develop a detailed project plan, defining objectives, timelines, and quality requirements.
Regular Progress Reporting: Through regular communication and reporting, we ensure that clients are informed of project progress and that any potential issues are addressed promptly.
Flexible Response to Changing Needs: During the project, if client requirements change, we can quickly adjust the production plan to ensure the smooth continuation of the project.
Raw Material Procurement and Management: Sourcing high-quality raw materials from carefully selected suppliers to ensure the continuity and quality of API production.
Global Logistics Support
: Collaborating closely with global logistics partners to ensure that APIs are delivered safely and promptly to the client’s specified location, supporting clinical trials worldwide.
Inventory Management: Providing flexible inventory management solutions for clients, ensuring that APIs are supplied on-demand at each clinical stage, avoiding delays and waste.
Pilot Production: Before process scale-up, we conduct pilot-scale production validation to ensure the feasibility and cost-effectiveness of the process.
Commercial Scale-Up: For APIs required for Phase III clinical trials and pre-market needs, we can further scale up the process to commercial production levels, ensuring large-scale supply.
Comprehensive Quality Control: Quality testing is conducted at every stage of production, using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure the purity, stability, and compliance of APIs.
GMP-Compliant Production
: Our production facilities and processes strictly adhere to international GMP standards, ensuring that each batch of API is produced in compliance with regulatory requirements.
Stability Studies: Conducting stability studies of APIs under different storage conditions to ensure their quality and efficacy throughout the clinical trial period.
Preclinical Research and Phase I Clinical Trials: At this stage, the demand for APIs is small but with high-quality requirements. We focus on small-batch production, ensuring product purity and consistency.
Phase II and Phase III Clinical Trials: As the scale of clinical trials expands, the demand for APIs increases. We have the capacity for pilot-scale and commercial-scale production, enabling flexible adjustments in production volume to meet clinical needs.
Multi-step Synthesis and Complex Molecule Production: Handling complex multi-step synthesis and the production of structurally complex molecules to meet the needs of specialized drug development.
