Our team brings decades of knowledge in RIM, from small businesses to multinationals. We are experts in regulatory submissions across the world and are familiar with local regulations, therefore we can support you in navigating the complexity and variability of regulations across regions. The ability to organize, structure, provide overview and analyze is part of our DNA.
We handle information management in multiple ways.
What we can do for you ›
- Gathering regulatory data from various sources (internal and external).
- Maintaining a database for regulatory documents and information.
- Preparing and submitting regulatory filings to authorities.
- Tracking submission statuses and timelines.
see also Electronic Submission Support
- Ensuring products and processes comply with current regulations.
- Monitoring regulatory changes and assessing their impact on your organization.
- Storing, organizing, and retrieving regulatory documents.
- Version control and audit trails for regulatory documents.
see also DMS Support
- Facilitating communication between regulatory teams, other departments, and external stakeholders.
- Collaborating on regulatory strategies and submissions.
- Generating reports for regulatory submissions, compliance status, and performance metrics.
- Analyzing regulatory data to identify trends and insights.
Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
Questions from our clients
FAQ Section
- Improves compliance and risk management: ensures adherence to regulatory requirements, reducing the risk of non-compliance.
- Increases efficiency: streamlines regulatory processes, saving time and resources.
- Strengthens Data Integrity: maintains accurate and up-to-date regulatory information.
- Enhances Collaboration: facilitates better communication and collaboration among regulatory and other teams.