ASEAN Common Technical Dossier (ACTD):This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements.
The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications — applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened — most study reports are not required to be submitted.
Module 1 in the CTD (the regional and registration information) is still present as Part I in the ACTD. ICH M2 is dropped and the summaries are absorbed into the subsequence parts. Quality information (ICH M3) is Part II of the ACTD, Nonclinical (ICH M4) is Part III, and Clinical (ICH M5) is Part IV.
ACTD DOSSIER STRUCTURE
PART I : ADMINISTRATIVE INFORMATION
Part II : Quality
Part III : Nonclinical Study Reports
Part IV : Clinical Study Reports.
Cyclone Pharmaceuticals Pvt Limited is India's leading Regulatory consultant and involves in compilation of ACTD Dossiers with complete review of document.
In last 2 years we got expertise in compilation and filling of ACTD Dossiers in various asian countries.CPPL understands the practicle issues and provides solutions to resolve the same.CPPL the dossier consultant are not only compiling dossiers but also involves in review and correction of documents.
With our experiance of DRUG DOSSIER Compilation we observed that many documents of manufacturer are inadequate or it's having loopholes and if such documents are directlly incorporated in dossier it is resulting in serious queary and delyes registration procedure,CPPL Team is belives compiling dossier is not a big task it's work of a computor operator but while compiling dossiers review of documents and suggesting appropriate corrections to minimise quearies is important and task of Technocrats,CPPL Regultaory team uns=derstands this and advise client on technical part of documents also and make your ACTD Dossier perfrct for registration
Why to Choose CPPL as your Regulatory and Dossier Partner
Knowledge of Pharmaceutical Technologies
Knowledge about formulation and analytical techniques
Minimises time of registration with it's Perfect dossier service
Complete Support for Generating documents like PV,AMV,Stability
Comparativelly very Low Cost (Do not compaire with computor operators who provide Dossiers free of cost)
Honest servives ,we says yes if it is possible and no if having any difficulties
To serve Pharmaceutical Industry with best quality services and to bring a Quality culture in Documentation and regulatory services
Note : CPPL The best regulatory service providers of India do not compete with any other service providers because we know we are best