Our Services & Technology: Your Strategic Pharmaceutical Partner
At Asia Talent Chemical, we go beyond simple supply. We are a solutions provider, leveraging our integrated network, technical expertise, and global reach to offer comprehensive services that add value at every stage of your project.
Core Services
1. Global Sourcing & Supply Chain Management
- One-Stop Sourcing: Access our vast, pre-vetted network of leading manufacturers (NCPC, Huahai, Harbin, Sanjing, etc.) across APIs, finished dosages, excipients, and health products.
- Supply Chain Integrity: We manage logistics, documentation, and quality assurance, ensuring a reliable, transparent, and efficient supply chain from the factory to your destination.
- Market Intelligence: We provide insights on supply trends, regulatory changes, and competitive landscapes in key markets (China, Asia, Europe, Americas).
2. Custom Synthesis & Contract Manufacturing
- From Development to Scale-Up: We connect you with specialized partners for custom synthesis of complex molecules, intermediates, and APIs, supporting projects from lab-scale R&D to commercial production.
- Technology Transfer: We facilitate seamless technology transfer for proprietary processes between your specifications and our manufacturing partners.
- Formulation Development: Access capabilities for developing sterile injectables (lyophilized powders), oral solids, and liquid formulations.
3. Regulatory & Compliance Support
- Documentation Package: We supply comprehensive regulatory documentation, including DMF/CEP references (where available), GMP certificates, and detailed Certificates of Analysis.
- Market Registration Support: Our expertise helps navigate registration pathways in various international markets by providing the necessary technical dossiers and quality data.
- Audit & Qualification Support: We coordinate and facilitate customer audits of our partner manufacturing sites.
4. Quality & Technical Services
- Specification Development & Review: Our technical team can help define or review product specifications to meet your target market requirements.
- Stability Study Management: We can arrange and monitor ICH-compliant stability studies for APIs and finished products.
- Troubleshooting & Analytical Support: Leverage our network’s laboratories for method development, validation, and investigating quality-related issues.
Technological Capabilities
Our partner network encompasses advanced manufacturing and analytical technologies, ensuring access to state-of-the-art solutions.
1. Advanced API Manufacturing
- High-Potency API (HPAPI) Handling: Safe and compliant manufacturing of oncology and other potent compounds.
- Polymorph & Salt Form Screening & Development: Expertise in developing stable and bioavailable crystalline forms (e.g., for products like Upadacitinib, Baricitinib).
- Biocatalysis & Green Chemistry: Utilization of enzymatic processes for efficient and sustainable synthesis (e.g., for key intermediates of Gabapentin, Pregabalin).
- Continuous Flow Chemistry: Implementation of flow technology for safer, more efficient, and scalable production of complex molecules.
2. Specialized Formulation Technologies
- Sterile Manufacturing: Advanced aseptic filling and lyophilization capabilities for β-lactam and non-β-lactam injectable powders.
- Cyclodextrin Complexation: Advanced drug delivery technology to enhance solubility, stability, and bioavailability of poorly soluble APIs (via partners like Binzhou Zhiyuan).
- Controlled-Release Formulations: Capabilities in developing modified-release solid oral dosage forms.
3. Stringent Analytical & Quality Control
- Modern Analytical Suite: Partners employ HPLC/UPLC, GC, GC-MS, LC-MS, ICP-MS, NMR, and XRD for comprehensive characterization and impurity profiling.
- Microbiological Laboratories: Fully equipped labs for sterility testing, bacterial endotoxin (LAL) testing, and microbiological examination.
- Stability Chambers: ICH-condition stability chambers for real-time and accelerated stability studies.
Our Value Proposition: The Asia Talent Advantage
- Integrated Network: We are your single point of contact to a diversified and robust manufacturing base.
- Technical Bridge: We translate your technical and regulatory needs into actionable specifications for our partners.
- Risk Mitigation: Our rigorous QA/QC and partner qualification process de-risks your supply chain.
- Speed to Market: Our established relationships and regulatory knowledge can accelerate your development and registration timelines.
Let us apply our services and technology to your challenges. Contact us to develop a customized partnership strategy.