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