As Director of Regulatory Affairs you must interact with regulatory authorities from pre-launch through the entire lifecycle and ensure your company can market and sell products by maintaining good standing with governing bodies. Your job is growing more complex as regulations grow more complex and your company expands into new countries and geographies. In this challenging environment, you must maintain documented, up to date regulatory procedures to ensure compliance.
As regulations grow more complex, it is critical to be able to demonstrate standardization and harmonization of regulatory processes. You must be always at the ready to support an audit through well documented processes and comprehensive reporting. The right technology can be the difference in managing a successful audit or registering a product in a timely manner.
Timeliness and accuracy are critical when managing requests from governing bodies. Regulatory processes rely on a large volume of data and multiple critical activities and stakeholders. Many companies attempt to manage these processes manually but are constrained by resources and disconnected data sources and processes. Leading organizations are leveraging technology to automate workflows to empower the organization and drive greater efficiency and effectives in responding to regulatory requirements.
With so many existing products and new products coming to market each year, tracking multiple product registration submissions through multiple countries can be overwhelming. You need a solution that tracks each submission and can provide you real time status and access to all data and documentation related to the submission. You also need the system to provide alerts regarding status and also to help manage when changes are made to products that will require resubmission.
Sparta Systems’ enterprise quality management and regulatory information management solutions enable companies to integrate their regulatory processes and capture information across the enterprise. Regulatory professionals are empowered to better manage risk and ensure country and region specific regulatory requirements are met in a timely manner.