At PharmaPrimes Laboratories, we specialize in the development of robust, patient-centric pharmaceutical formulations. Our R&D team supports drug development from concept through commercialization, integrating formulation science, analytical development, stability assessment, scale-up, and regulatory documentation.
We design customized formulation strategies based on the physicochemical characteristics of the drug substance, target product profile, dosage form, and development objectives.
Development activities may include pre-formulation assessment, excipient selection, prototype development, formulation optimization, and evaluation of critical formulation variables.
We support the transition from laboratory-scale development through pilot-scale and scale-up activities, with focus on process reproducibility, scalability, and technology-transfer readiness.
Purpose-built analytical methods are developed and validated in accordance with applicable regulatory requirements and current ICH Q2(R2) principles.
Methods may support formulation development, product characterization, release testing, and stability programs.
Support for preparation and review of development documentation including formulation development reports, analytical method validation documentation, and stability data packages for regulatory dossiers.
PharmaPrimes provides scientific due diligence and pharmaceutical dossier assessment to support licensing, acquisition, investment, and development decisions.
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.
Scientific and regulatory support including pharmaceutical dossier assessment, CTD documentation support, scientific justification, and regulatory submission support.
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.
Share your target product profile and development objectives, and our formulation and analytical scientists will propose a tailored development plan.
