Pharmaceutical industry is regulated to a variable extent across the world. While Regulatory agencies require Pharmaceutical Dossiers to gain approval to market drugs. The Pharmaceutical Dossiers comprises of various documents representing years of research that includes multi-disciplinary information (including preclinical/clinical data) regarding the safety and efficacy of a drug.
Pharmaceutical Dossier Management
Because The regulatory process requiring Dossier Submissions vary from country to country and involves numerous interactions between the submitting company (sponsor) and the regulatory authority (agency).
Therefore The burden of compiling documentation and presenting it in a compliant format rests on the sponsor’s (company’s) shoulders. This process is very complex involving considerable costs and requiring management of all the components during the approval process.
Our core focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossier Writing. We are have been involved with all aspects of regulatory affairs, from supporting Clinical trials, bioequivalence reports, validation data, Expert reports, Data for Overview, PSUR through registration activities, compilation of Pharmaceutical dossier and application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry.
finally Pharmaceutical dossier is highly detailed/exhaustive document on the drugs which requires extensive data’s on its various aspects. Document compilation requires skills of sourcing, interpreting and writing this document. In conclusion This process of Pharma dossier compilation needs a talented team of pharmacists, data analysts and research assistants.Therefore the entire procedure is highly time consuming and costly. For this Pharma dossier compilation and writing.