Pharmaceutical companies have been manually handling large amounts of paper based documentation required for regulatory submissions. Numerous copies of these bulk documents are sent to regulatory authorities for review and archiving leading to hassles of data storage. The process was complicated and involved huge investments of time, money and manual effort. The whole process was recycled when reviews and auditing occurs throughout the document lifecycle. Industry segments and regulators realized the need for standardizing the process and automating submissions would be a great relief. ClinAsia Labs believes eCTD is the solution to all these issues.

ClinAsia Labs Process team has vast past success record along with experience in electronic submission processes, submission lifecycle management and version control. Clients seek our experts because of their ethical combination of process and technology expertise. They are specially trained and equipped to understand the business as well as the standards and technologies that automate it.

ClinAsia Labs eCTD can be treated and rated as industry to regulatory authority interface, encouraging the transfer of information from industry to the reviewing authority at ease and will:

• ClinAsia Labs eCTD will also facilitate easy and organized authority review of your product properly organized documentation in compliance to the regulatory guidelines and offer high value addition in a short time to market.

• ClinAsia Labs eCTD is a value added organized live document that is specially designed to evolve through the complete life cycle of your product and will always ensure its reflection regulatory changes made to your drug documentation.
  
  
• ClinAsia Labs eCTD helps you meet regulatory compliance because ClinAsia Labs is always up to date with all registered and approved data in one place according to the regulatory guidelines.