CTD Dossiers

CTD Dossiers

Backed by the well trained staff, we as a Service Provider offer CTD Dossiers services. Renowned for its effective and systematic execution, the services on offer are provided by a team of skilled experts. At our end, we make sure the quality of our services is never compromised. The timely execution of services makes us an instant hit among the clients. These quality services are made available by us for a cost effective fee for our valued clients. Get in touch to avail our services.

Additional Information
BDK Lifesciences Pvt. Ltd., a growing Global Pharmaceutical Regulatory Affairs Consultants based in Delhi INDIA prepares the CTD Dossiers as per the CTD Dossiers guidelines. We,at BDK Lifesciences Pvt. Ltd.(Pharmaceutical Dossier Consultants) provide our regulatory services to pharmaceutical companies to overcome the challenges within the rapidly evolving global pharmaceutical market.

Dossier is an integral Part of any registration application for Marketing Authorization. Dossier is submitted to Food & Drug Authority or Ministry of health or any other equivalent authority along with other required documents.

BDK Lifesciences Pvt. Ltd. has successfully prepared the CTD dossiers that lead to the marketing authorization by the Regulatory Agencies of the various countries.

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 : Pre-clinical Study Reports
  • Module 5 : Clinical Study Reports (Clinical studies)