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Integrated Pharmaceutical Development, Testing & Clinical Research Services
From early formulation through regulatory submission and lifecycle management, PharmaPrimes connects pharmaceutical R&D, analytical testing, bioanalysis, biosimilar services, clinical research, model-informed drug development, and regulatory support within one organization.
Formulation development, process development and optimization, analytical method development and validation, stability studies, regulatory documentation support, and pharmaceutical dossier assessment.
Comprehensive testing of APIs, raw materials, finished products, and stability samples, including impurity analysis, dissolution, elemental impurities, residual solvents, Extractables & Leachables, physical testing, and analytical method development.
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.
Bioanalytical support for small molecules, peptides, therapeutic proteins, monoclonal antibodies, and biologics across preclinical, clinical, bioequivalence, and biosimilar programs.
Analytical characterization, purity and heterogeneity assessment, glycosylation profiling, biological activity, process-related impurity testing, clinical PK, and immunogenicity support.
Hospital-based clinical research through the PharmaPrimes Clinical Research Center located within Jordan Hospital in Amman.
Integrated clinical and bioanalytical support for BE/BA studies and pharmacokinetic evaluation.
Model-Informed Drug Development using PBPK/PBBM modeling and Virtual Bioequivalence simulations.
Scientific and regulatory support including pharmaceutical dossier assessment, CTD documentation support, scientific justification, and regulatory submission support.
Tell us about your program and our scientific team will prepare a tailored proposal.
