method transfer

BioAgilytix is a global bioanalytical laboratory and contract QC laboratory providing pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in a GxP environment for pharmaceutical and biotechnology organizations throughout every phase of drug development. It maintains laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany.

assay development and validationcell-based assaysFlow CytometryGMP testingkit productionlab automation systemsLBA/immunoassaysmass spectrometrymolecular assaysQC release and stability testingvirology

CMC Pharma is a small molecule contract development and manufacturing organization (CDMO) providing end-to-end CMC (Chemistry, Manufacturing, and Controls) drug development services. It offers formulation and process development, analytical chemistry, ICH stability and compatibility testing, method transfer, scale-up and tech transfer, CMO selection and oversight, and integrated regulatory support for IND/NDA submissions. The company operates cGMP laboratories and a pilot plant for non-GMP small batch production but does not own a commercial GMP manufact

analytical method development and validationcGMP complianceCMO management and oversightcompatibility assessmentsdissolution studiesforced degradation studiesformulation developmentICH stability testingpilot plant small batch productionprocess developmentregulatory submission supportrelease testingscale-uptech transfer

Emery Pharma is a full-service Contract Research Organization (CRO) and GLP/cGMP-compliant contract research laboratory based in Alameda, California. It supports preclinical drug development with analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and general R&D and cGMP/GLP support, delivering customized solutions to fit clients' outsourcing needs.

analytical method developmentbioanalytical assaysbiologics characterizationELISA and MSD immunoassaysGC-MSGLP/cGMP compliancehigh-resolution mass spectrometryHPLC/UPLCLC-MSLC-MS/MSmetabolomicsmethod validationmicrobiology testingNMRproteomicsstability testing