X Pharma Plus ensures that all your dossier authoring needs meet global regulatory standards for quality, safety, and efficacy. We provide expert regulatory support for the registration of human medicinal products—from oral solids and parenteral to the most complex therapies. With deep expertise across all therapeutic categories, we deliver a right-first-time quality approach to accelerate approvals and bring your products to market faster.
Dossier Authoring Services– Overview
A robust Common Technical Document (CTD) dossier provides Health Authorities (HAs) with complete technical and scientific information necessary to evaluate the quality, safety, and efficacy of human medicinal products. X Pharma Plus leverages its dossier authoring expertise to support product registration by delivering comprehensive, HA-compliant documentation and strategic recommendations to meet regulatory requirements.
From initial product registration to global market expansion, our experts ensure all regulatory expectations are met to avoid HA rejections. We facilitate successful, on-time approvals by providing complete support during HA reviews and maintaining compliance throughout the product lifecycle. By authoring high-quality dossiers that adhere to global regulatory standards, X Pharma Plus enables manufacturers and sponsors to achieve timely approvals and expedited market entry.
Dossier Authoring Services
“End-to-end preparation and compilation of regulatory documents in CTD/eCTD formats for global submissions.”
Common Technical Document (CTD) Services
Streamlined, comprehensive CTD templates designed to meet global regulatory standards and ensure submission excellence.
Biologics Registration Services
Expert support for the seamless registration of biologics across multiple international markets, simplifying complex regulatory pathways.
