ACTD DOSSIERS

ACTD Dossier Services

We, at BDK Lifesciences Pvt Ltd, being a distinguished name in the market, indulge ourselves in offering ACTD Dossiers services. We meet the customized requirements of the clients being a devoted Service Provider. Our dependable services are applauded worldwide by our clients. Our team of qualified professional is well versed with latest trends in our field. For providing consistently outstanding services, our experts consult the clients to know their specific requirements and plan accordingly to provide the best services. The services on offer are available for a reasonable fee.

The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN We, being a distinguished name in the market, indulge ourselves in offering ACTD Dossiers services. We meet the customized requirements of the clients being a devoted Service Provider. Our dependable services are applauded worldwide by our clients. Our team of qualified professional is well versed with latest trends in our field. For providing consistently outstanding services, our experts consult the clients to know their specific requirements and plan accordingly to provide the best services. The services on offer are available for a reasonable fee.

What is ACTD ?

ACTD, 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.
Common Technical Document for ASEAN countries contains of four parts :-

Part I : Administrative information
Part II : Quality
Part III : Nonclinical Study Reports
Part IV : Clinical Study Reports


Additional Information:
  • Delivery Time: Within 5 Working Days