Dossier Services

Deeply rooted in Gomti Nagar, Lucknow, Uttar Pradesh, we are an organization that renders excellent CTD and ECTD dossier preparation services to the clients at competitive charges. ECTD means an electronic common technical document that is required by the pharmaceutical industry for transferring regulatory information. Thus, CTD & ECTD is an essential documentation that requires the right assistance. We are a group of committed professionals who strive to provide proficient solutions to our valuable clients.The Common Technical Document is divided into five modules : Module 1 : Administrative information and prescribing information Module 2 : Common Technical Document Summaries (Overview and summary of modules 3 to 5) Module 3 : Quality Module 4 : Preclinical Study Reports Module 5 : Clinical Study Reports (Clinical studies)

Sarims provides consulting and dossier solution for product registration. We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline).Administrative Documentation (writing and review): Registration Application & Covering Letter Letter of Authorisation Legal & Administrative (GMP,CoPP, FSC etc) Documents Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert Label and carton contents Technical Documentation (writing and review): Summaries – Quality & Non-clinical Drug master file (S Part of Dossier) Non-clinical Overview (Module 2) PDR, Process validation, AMV & Stability Studies Specification, Method of analysis & Certificate of Analysis of Raw materials & Packing Materials Specification, Method of analysis & Certificate of Analysis of Formulation product Module 4 (Non-clinical) Module 5 (Non-clinical)   Common Technical Document (CTD) -The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed as per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)We prepare all modules of Common Technical Document: Module 1. Administrative information and prescribing information Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5) Module 3. Quality Module 4. Nonclinical Study Reports (toxicology studies) Module 5. Clinical Study Reports

• Dossier: Dossier Compelling

Services offered by PHARMA HOUSE   Dossiers (CTD, e-CTD, ANDA and ANVISA)  (All Country Specific, As per client request)   DMFs(CTD, e-CTD)(Open &Closed part)  (All Regions and Country regulations)   Technology transfers(API'S &Formulations), ( Paper technology & Product Development)    Pharmacovigilance(PV),  Intellectual properties(IP)   AMV, BMR, BPR AND BE Reports (As per country specifications)   We have seperate Teams for Product Development for API'S &Formulations.   All product Documentations (Process, training, trouble shooting)  &other Regulatory services

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Registration dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved registered marketed in a country.

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 provide CTD / Dossier compilation services for US and Europe market of human drug products.

Herbal Dossier Compiling / Writing\r\n\r\nHerbal drugs are getting higher acceptance as an alternative medicine. Therefore some countries have started the registration for herbal drugs as well. Recently we are working on compiling and writing herbal dossiers too.\r\nPharma CTD / ACTD Dossier\r\n\r\nDrug regulatory affairs in pharma industries has mandated two types of dossier namely CTD ( Common Technical Dossier) and ACTD ( Asian Common Technical Dossier ). Regulated pharma markets (eg.USA, Europe ) markets require submission of dossier in CTD format which has to provide clinical trial and bioequivalence studies. As against this, semi-regulated pharma markets (South East Asian and Gulf Countries) require ACTD format which does not require exhaustive details like CTD.

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

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

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 services for ROW Export Market

• Dossier: Dossier Compelling

We provide Services to international buyers who want to register pharmaceutical products in their markets, by preparing all dossiers and regulatory information required for registration. We provide Services to international buyers who want to register pharmaceutical products in their markets, by preparing all dossiers and regulatory information required for registration. We also assist these buyers to identify the suppliers or manufacturers.

eCTD DOSSIER PREPARTIN, PHARMA REGULATORY, regulatory consulting services

dossier preparation services, amyl meta cresol, Eugenol (CAS No: 93-15-2)

dossier services, HONEVERA HERBAL COUGH SYRUP, Tooth Powder, throat lozenges

dossier services, Ondansetron, Microcrystalline Cellulose, Diclofenac Sodium

CTD / ACTD / eCTD Regulatory Dossier Preparation Services

Registration Dossiers For Thailand

Dossier Compilation Service, Product Analysis, analytical method development