J2fpharma

J2Fpharma, SAS, is a consulting services company dedicated to provide support & expertise on. Pharmaceutical development->Formulation (all pharmaceutical forms) for NCEs, Generics, lifecycle management, using Quality by Design approach->Analytical Development & stability studies (eg: validation protocol & report, choice of packaging)->PK studies (eg: support in design, vitro-vivo correlation, bioequivalence, identify partner CRO)->Scale-up / Industrialization (eg: process optimization, site transfer, documentation)-> Site audit. J2Fpharma can be your partner to assist you throughout a specific project from its feasibility to development strategies and CTD dossier redaction or to act as external expert with a dedicated technical support at some stage of your development. CMC regulatory->Strategies & advices at all steps (from lab scale to product registration and post-approval changes)->CTD dossier redaction (module 2 & 3) finely tuned to meet country requirements->Technical dossier redaction to support clinical studies (IMPD, IND,…)->Scientific advice and meetings with Regulatory agencies->Questions & Answers process with Regulatory agencies->Audit of CTD dossier. J2Fpharma can be your close regulatory partner for CMC topics, making the most of its experience with worldwide submissions (from Europe, to US-FDA, WHO, Asia, Africa, GCC and EAEU). J2Fpharma experts are also available to provide a large catalog of trainings covering pharmaceutical development and CMC fields, such as."Country-dependent CMC requirements"."How to manage statistics as per ANVISA (Brazil) requirements"."Quality by Design: from developemnt to CTD dossier redaction"."CMC requirements for dossier submisson in US-FDA". J2Fpharma teams has more than 35 years of experience in pharmaceutical industry, making the most of it to provide suitable solutions and services to meet clients needs. Do not hesitate to contact us! contact@j2fpharma.com