Regulatory authorities require registration of all medical products intended for human use or consumption. In some cases such as in pharmaceutical and biologic products each marketed dosage and package needs to be registered and approved.
Product registration is the act of gaining permission to sell your product in specific markets. You’ll need to gain approval to sell a new product, to renew the license for older product and for every change that is related to the product. To gain these approvals you’ll have to follow specific requirements each regulatory authority demands. Tracking your product registration will give you valuable information about the products you sell in different countries. It will also help you with answering queries about the product, adverse event reporting, product related changes and more.
Simploud automates the registration process at a global and local or regional levels. Doing this improves the overall processing time of all the regulatory activities which means finally a better time‐to‐market. Simploud can also calculate timelines based on different rules and initiate reminders and actions based on this schedule. Using the Simploud process will proactively drive all the submission activities forward and increase the efficiency of your regulatory work.
Product registration follows a process which can vary based on specific countries, dynamic workflows are available to support individual workflow requirements.
Simploud’s drag and drop reporting and dashboard tools provide up to date status information on product registrations, enabling companies to know exactly where it stands with each submission in each country. As a result, it improves visibility and transparency across the organization, giving users and management a global view of potential delays and resource conflicts, and enabling faster, informed decision making at lower cost. In addition the visibility on all aspects of the product status globally will enable a quick impact analysis of every change and will automate all the actions required as a result of this change.