USV PHARMA SOLUTIONS Lajpat Nagar, Delhi

Common technical documents (ctd) is set of specification describing a specific format for registration dossiers which will be accepted by countries following ich guidelines. Dossier is a document which contain complete detailed information about a drug. Dossier in pharmaceutical field are used to obtain marketing authorization across different nations. Ctd formats dossier is now being adopted by many nations. Our expertise • preparing & compiling dossier for any dosage form.(tablets, capsule, syrup, vials etc) • complete support from collecting data for dossier to compilation and submission of dossier in various countries • preparation of asian ctd - actd dossiers for asean countries • re-formatting of old dossier to ctd as per ich guidelines • answering post submission query raised by moh of respective countries • preparing pack inserts, spl, periodic safety reports (psurs) • writing of expert reports, preparation of module 4 non - clinical & clinical modules along with overview module 2.4 & 2.5 of ctd our experience • prepared & compiled more than 400 dossier in various dosage forms for submission to asian countries, russian, ukraine, algeria, middle east countries, north american countries, african countries, european countries (ctd), brazil (anvisa), us (ctd),australia , new zealand, india (dcgi) • quality expert summary for more than 100 products for regulated & semi regulated market • worked more than 100 companies all around the world • carrying out various analytical test like structural elucidation studies (elemental analysis, ir, mass, nmr c & h, xrd, dsc), analytical method validation, process validation and stability data for api, determination & validation of potential impurities & solvent impurities from reputed analytical labs having nabl certification. Our services are tailored to meet clients requirements, and add value to their company by minimizing both time and money spent