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Primera Analytical Solutions is a cGMP and GLP CRO in great standing with the FDA. Our primary objectives are quality and to become a trusted partner. Services include method development/validation, method transfer, impurity studies (LC/MS/MS, GC/MS, ICP/MS), extractable and leachable studies, stability studies, dissolution, abuse-deterrent studies, solid state characterization, product and raw material release testing. We also offer bioanalytical, biopharmaceutical and DMPK testing. Services include PK/PD, metabolite characterization, bioavailability and bioequivalence studies, bioassay method development and validation, impurities by ELISA, anti-drug assay (ADA), peptide mapping and so much more.
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