SOLUTIONS > REGULATORY MANAGEMENT

Regulatory Management

Unified regulatory management processes simplify submissions, accelerate time to market, and ensure compliance

Simplify regulatory compliance

Regulatory compliance is critical throughout a product’s lifecycle, from ideation to post-marketing commitments. A unified regulatory management solution streamlines processes, ensuring product approval and market access.

Navigate Regulatory Complexity

Life sciences organizations face constant change in global regulatory requirements. Dot Compliance helps teams stay ahead by centralizing compliance activities and simplifying the management of FDA, EMA, and other regional regulations. With built-in automation and traceability, companies can efficiently adapt to evolving standards while maintaining full visibility and control.

Automate Processes

Digital workflows replace manual steps, enhancing efficiency and reducing the risk of errors during submissions and approvals. Automation ensures consistent documentation, accurate version control, and faster response times to regulatory changes. This streamlined approach allows teams to meet modern compliance expectations with confidence and precision.

Unify Regulatory Data

Integrated systems eliminate data silos, connecting quality, regulatory, and operations teams within one platform. Real-time visibility enables seamless tracking of submissions, reviews, and approvals across regions. By centralizing data and collaboration, organizations can accelerate decision-making and maintain alignment with global regulatory requirements.

Get a complete and cost-effective regulatory management solution with Dot Compliance

Dot Compliance’s regulatory management solution empowers organizations to respond faster to changing regulations and helps coordinate regulatory efforts between the organization, partners, and regulatory authorities. Organizations can handle regulatory product data management, registration planning and tracking, dossier management, document and data management, and regulatory correspondence in one user-friendly system.

Features and Benefits

Global planning & tracking

Proactively plan, track, and assess regulatory compliance impact across global product portfolios. Create and manage dossier files and binders in a flexible or predefined structure.

Increased visibility

Manage the end-to-end global registration and dossier process, including regulatory interactions and commitments. Track the entire product lifecycle with advanced metrics and KPI reporting through easy-to-use reports and dashboards.

Improved collaboration

Engage internal and external stakeholders across interconnected processes from the beginning. Standardized document and data input by affiliates, partners, and all departments within the organization. Streamline regulatory and quality processes under one system. The solution is compliant with industry standards such as 21 CFR Part 11 and includes a validation package and project validation services.

The eQMS that keeps you one step ahead

Dot Compliance is the industry’s first AI-powered eQMS, built to get you up and running fast – and to give you the insights to drive quality efficiently.