At Chalcogen Pharma, we provide expert consultation services for Analytical Development and Validation, ensuring pharmaceutical and chemical companies achieve the highest quality and regulatory compliance in their analytical processes. Our team of specialists offers customized solutions to support method development, validation, and analytical troubleshooting, enabling seamless regulatory approvals and product integrity.
Analytical Method Development: We design and optimize robust analytical methods tailored to specific product requirements.
Method Validation: Comprehensive validation services in accordance with ICH guidelines, ensuring accuracy, precision, and reliability.
Regulatory Compliance Support: Assistance with regulatory submissions and documentation, including CTD, DMF, and dossier preparation.
Analytical Troubleshooting & Optimization: Identifying and resolving analytical challenges to improve efficiency and compliance.
Technology Transfer & Training: Seamless transition of validated methods to manufacturing sites, along with expert training for in-house teams.
GMP & GLP Compliance Consulting: Ensuring adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) for regulatory approval.
HPLC, UPLC, GC, and LC-MS Method Development & Validation
Stability Studies & Forced Degradation Analysis
Residual Solvent and Impurity Profiling
Dissolution and Bioavailability Studies
Elemental Impurity and Heavy Metal Analysis
Data Integrity and Compliance Audits
Comparability Studies for Drug Substances and Drug Products
Microbial and Endotoxin Testing
Extractable and Leachable Studies for Packaging Materials
At Chalcogen Pharma, we are dedicated to delivering precise, reliable, and compliant analytical solutions. Partner with us for expert guidance and seamless execution of your analytical development and validation needs. Contact us today to learn more about how we can support your business!
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