Technical Support
Comprehensive documentation, regulatory guidance, and technical expertise ensure your product's success from development to manufacturing scale-up.
1.Documentation Support
What documentation support do you provide after delivery?
We provide a complete and traceable documentation package to support quality review, regulatory submission, and internal validation throughout the product lifecycle.
- Certificate of Analysis (COA)
- Original HPLC / MS / NMR spectra
- Batch Manufacturing / Production Records (BMR / BPR)
- Residual solvents, microbial limits, and elemental impurities test reports
- TSE/BSE statement and animal-origin-free declaration
- Stability study data (Accelerated / Long-term)
- Material Safety Data Sheet (MSDS / SDS)
2. Regulatory Support
How do you support regulatory filing and DMF submission?
We offer regulatory-oriented technical support to facilitate drug registration and regulatory review in major markets.
- Drug Master File (DMF) filing
- Provision of quality specifications and safety-related documents required for registration
- Assistance in responding to technical inquiries from regulatory agencies (e.g., FDA / EMA)
3. Technical & Quality Support
Our technical team provides in-depth scientific support covering structure confirmation, analytical interpretation, and practical application guidance.
- Structural confirmation and interpretation for peptide APIs
- Purity and impurity profile analysis support
- Recommendations for reconstitution, lyophilization, dissolution, dilution, and filtration
- Professional guidance on usage and storage conditions
- Reference basis for impurity limit establishment
- Assistance in establishing or validating customer-specific HPLC methods
4. Customization Services
We provide a complete and traceable documentation package to support quality review, regulatory submission, and internal validation throughout the product lifecycle.
- Certificate of Analysis (COA)
- Original HPLC / MS / NMR spectra
- Batch Manufacturing / Production Records (BMR / BPR)
- Residual solvents, microbial limits, and elemental impurities test reports
- TSE/BSE statement and animal-origin-free declaration
- Stability study data (Accelerated / Long-term)
- Material Safety Data Sheet (MSDS / SDS)
5.Quality & Compliance Support
We support customer quality audits and compliance reviews with transparent documentation and traceable systems.
- Quality system documentation (e.g., QMS summary)
- Product Quality Review (PQR / APR)
- Support for customer audits (on-site or remote)
- Supply chain traceability support
6. After-Sales Quality Response
We implement a structured and timely response mechanism to address quality-related concerns after delivery.
- Consultation regarding batch-to-batch variation
- Stability assessment for transportation issues or temperature excursions
- Product deviation investigation report
- CAPA (Corrective and Preventive Actions) support