PharmaPrimes provides scientific and regulatory support throughout pharmaceutical development, helping sponsors organize, assess, and prepare technical information for regulatory submissions and development decisions.
Support for preparing and reviewing technical sections of CTD dossiers.
Formulation and process development reports.
Review of analytical methods, specifications, and data packages.
Preparation and review of method validation documentation.
Organization and review of stability data for submission.
Scientific assessment of pharmaceutical dossiers.
Identification of documentation and development gaps.
Scientifically reasoned justifications supporting development and submission strategies.
Support for responding to regulatory questions and deficiency letters.
Scientific due diligence supporting licensing, acquisition, and investment decisions.
PharmaPrimes provides scientific and documentation support. Regulatory decisions remain the responsibility of the relevant authorities, and no specific regulatory outcome is guaranteed.
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.
Share your dossier status and timelines, and our regulatory and scientific team will propose how we can support you.
