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
European CTD
ASEAN
USFDA
ROW countries
GCC countries
non-CTD (country specific guideline
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