Primera Analytical Solutions is a GLP and GMP CRO in great standing with the FDA. Our primary objectives are quality and to become a trusted partner. Services include:- Large and small molecule CMC, bioanalytical, release testing. Method development/validation, method transfer (Assay, Impurities, Dissolution, PK/PD, ADA, cell-based/non cell-based NAb)- Cell & Gene Therapy (FACS, qPCR, ddPCR, cell-based assays- Cell potency assays- 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- Metabolite characterization, bioavailability and bioequivalence studies- Bioassay method development and validation- Impurities by ELISA- Peptide mapping- HRMS