Dossier Services

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

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.

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)

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

Dossier Services for ROW Export Marke

Dossier Development Services, Analytical Development Service

Dossier Services, GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SERVICE

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.

Dossier Services, Ondansetron, Microcrystalline Cellulose, Diclofenac Sodiu

Dossier Service

Flight Dossier Software, ERP Services, Process Optimizatio

Registration Dossier

Dossier Services, Regulatory Affairs Servic

Registration Dossiers Service

Pharmaceutical Dossier, Adhesives, Acaricide, Cosmetic Soa

Dossier Services, Pharmaceutical Formulations, Disposable Infusion Se

Dossier Services, Pharmaceutical Consultants, Pharmaceutical Product

Dossiers Development Services, Pharmaceutical Syrup, Pharmaceutical Table

Dossier Compilation Service, Product Analysis, Analytical Method Developmen

CTD - Dossier Services, Core Regulatory Services, Air Filter Cartridg

CTD / ACTD / eCTD Regulatory Dossier Preparation Service

eCTD DOSSIER PREPARTIN, PHARMA REGULATORY, Regulatory Consulting Service

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 Preparation Services, Amyl Meta Creso

Dossier Service

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