Analytical service & Regulatory service
We develop and validate methodologies for over 30 raw materials, intermediates, and finished drug products annually, as well as 1-3 drug formulations.
Method Development
Our experienced method developers have many years of experience in developing a wide range of products, developing methods and applying a variety of analytical techniques to ensure successful results. Leveraging our laboratories equipped with advanced analytical instrumentation, we can develop analytical methods that meet your specific needs.
Method Validation
Haizhou Pharma’s analytical team has a comprehensive understanding of analytical method validation requirements, which can be tailored to the different stages of clinical development. To ensure regulatory compliance, we adhere to relevant ICH guidelines, such as ICH Q2(R1), or pharmacopoeial guidelines and incorporate client-specific protocols. A detailed report is provided upon completion of the work.
Drug Release Testing
Haizhou has extensive experience in release testing, primarily for chemical raw materials, intermediates, and APIs (active pharmaceutical ingredients).
We are experienced and skilled in handling highly toxic and regulated substances. Release testing includes a variety of tests designed to assess product purity, concentration, consistency, identity and safety. Typical tests include appearance, impurity testing (related substances, residual solvents, inorganic ions, toxic impurities, etc.), assay testing, and microbiological testing. The methods used must be reliable to ensure product safety and integrity and reproducible to minimize non-conformances or deviations from specifications. In addition to conducting testing, we also develop and validate methods, frequently transferring methods from client and third-party sites.
Microbiological Testing
Microbiological testing provides information and understanding on the presence of microorganisms and toxins in raw materials, intermediates and finished products. We offer microbiological testing, microbial limits and endotoxin method development and validation, as well as test release.
Our microbiological testing services utilize internationally recognized standard methods, including those in the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP) and the Chinese Pharmacopoeia (CP). We also have the capability to develop customized microbial testing methods to meet specific client needs, having extensive experience in cGMP microbiological testing of raw materials, finished products and water systems.
Drug Stability Testing and Storage
Haizhou Laboratory provides comprehensive, cost-effective, GMP-compliant stability testing, study management and stability storage services, adhering to relevant cGMP and ICH regulations. Our comprehensive stability services encompass protocol design, analytical method transfer, study management, sample analysis and the issuance of quality management-approved reports.
Genotoxic Impurity Testing
Haizhou Laboratory is equipped with a comprehensive range of cGMP-compliant spectroscopy and chromatography equipment, including LC-MS and GC-MS. Our experienced team is capable of developing high-quality methods for detecting genotoxic impurity residues and conducting methodological validation.
Regulatory support team
Our regulatory support team is crucial for pharma product development and service, from licensing support to various levels of compliance. Our expertise in regulations, quality research and EHS will ensure the project from our customers to meet global regulatory requirements, from REACH to HALAL, from approval of US FDA, EDQM to other worldwide national regulatory structures.
We can assist in the preparation of drug master files for the EU, USA, China and Japan as well as further worldwide markets. The documentation for drug substances are in eCTD format (which facilitates ease of usage). In addition, we also support the market for drafting, review and submission of documentation for NDAs (US New Drug Applications) and MAAs (EU Marketing Authorization Applications). In accordance with compliance requirements, and integrity towards our customers, notifications of change are strictly adhered to in our company.
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