Dossier Services in Delhi

Dossiers (ctd) compilation for submissions in: asia africa middle east central america south america north america dossier compilation in common technical dossier (ctd) format and conversion to ectd for: us fda saudi fda european counties dmf (drug master file) and cep.

We cover asean, african countries, middle east countries, latin america, cis (common wealth of independent states) etc.

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

Details : Our Consultants team provides accurate documentation compliant with guidelines and regulations. Our highly qualified staff will work closely with your team to produce precise documentation for a wide variety of drug therapeutic areas and medical device categories. Our staff have scientific degrees and have experiences in many therapeutic areas. Our Consultants team averages over 10 years of experience. And no matter what template, writing style or electronic document management system you follow, they will write and finalize documents within your specifications. Our regulatory submission services include : •Drug submissions: IND, NDA, CTD, ANDAs etc. •Medical Device submissions: Registration Certificate, Import License, Test License, Clinical Trail application , shelf Life Approval, Model Addition to the existing registered Products, Notification and clarification for major and minor changes, adding new indication to already registered products, endorsement app to the Registration Certificate •Investigator’s Brochures and Briefing Documents •Clinical Trial Documentation: Protocols, Informed Consent Forms, and ICH-compliant Clinical Study Reports •Cosmetics Submission: Registration Certificate, Notification and clarification for major and minor changes, endorsement app to the Registration Certificate

Dossier Consultancy Service, textile inspection service

dossier services