PharmaPrimes provides comprehensive pharmaceutical testing services for drug substances, raw materials, finished pharmaceutical products, and stability samples.
Our analytical laboratories combine advanced instrumentation with experienced scientific teams to support product characterization, quality control, development investigations, and regulatory requirements.
Evaluation of extractables and leachables associated with pharmaceutical packaging systems and manufacturing components using appropriate analytical techniques including LC-MS/MS, GC-MS/MS, and ICP-MS.
Studies are designed with reference to applicable frameworks including ICH Q3E and USP <1663>/<1664>.
Identification and quantification of process-related impurities and degradation products.
Development, optimization, and validation of analytical methods according to applicable regulatory and ICH requirements.
Testing is selected as applicable to the dosage form, product specification, and regulatory requirements.
Testing of active pharmaceutical ingredients and raw materials, as applicable to the material and its specification.
Testing is performed under established quality systems. ISO/IEC 17025 accreditation applies to the specific tests listed in the accredited scope; details of the current scope are available on request.
Nitrosamine and NDSRI risk assessment, LC-MS/MS and GC-MS/MS method development and validation, confirmatory testing, routine analysis, root-cause investigation, and mitigation support.
Formulation development, process development and optimization, analytical method development and validation, stability studies, regulatory documentation support, and pharmaceutical dossier assessment.
Scientific and regulatory support including pharmaceutical dossier assessment, CTD documentation support, scientific justification, and regulatory submission support.
Send us your product details, specifications, and testing requirements, and our analytical team will respond with a tailored proposal.
