Regulations are in constant flux. Companies product and country strategies keep changing. Product lifecycle changes bring opportunities and risks.
You can search single or multi country requirements for different business/functional areas including clinical, IRB, market launches, CMC, GMP standards, submission checklists, fees, labeling, import/export, marketing, safety/Vigilance, renewals/variations and life cycle requirements
With a detailed alerting engine, you can rely on our regulatory monitoring process. Once you receive alerts (regulatory and standards), you can take next steps like sharing internally/externally, collaborating (with our Collaborate/Review functionality) with both internal/external stake holders on next steps (like document preparation or a project preparation) using workflow and our online commenting functionality. You can also opt for specific preferences by country and by functional area to get focused alerts.
The purpose of RIA is to ensure that regulations are effective, efficient, and beneficial to the company while minimizing negative impacts. With our assessment module, Regulatory teams can cut down cycle (waiting) time and feel less burdened clearing their “to-do” lists
RIA typically involves several steps, including:
1. Problem identification: Identifying the issue or problem that the regulation is intended to address.
2. Strategy development: Developing a range of policy options to address the problem.
3. Impact analysis: Assessing the potential impacts of each option, including the economic and patient safety impacts.
4. Consultation: Consulting with stakeholders and affected parties to gather feedback on the proposed options.
5. Decision-making: Selecting the preferred option based on the analysis and consultation.
6. Monitoring (Project Monitoring) and review: Monitoring the implementation of the regulation and reviewing its impact over time.
RIA is a valuable tool for Regulatory teams because it can help them identify the most effective and efficient options while minimizing unintended consequences.