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Software Status:Active

About RegulatoryOne

RegulatoryOne is a regulatory software platform from IQVIA that enables life sciences organizations to accelerate advancement and improve patient outcomes. It provides features such as regulatory submissions management, document management, and compliance tracking so organizations can bring treatments to market faster. The platform supports global regulatory requirements and improves collaboration among teams by offering a centralized system for managing regulatory processes. RegulatoryOne is designed to help organizations navigate complex regulatory environments effectively, ensuring compliance and improved workflows. Key capabilities: regulatory submissions management document management compliance tracking analytics and reporting global regulatory insights Best for: life sciences professionals that need to manage regulatory processes efficiently.

RegulatoryOne Details

Vendor
IQVIA
Year Launched
Location
One IMS Drive, Plymouth Meeting, PA 19462, United States
Deployment
Training Options
demo, account manager, community
Countries Served
All Countries
Languages
English, Spanish, French, German, Italian, Portuguese, Japanese, Chinese
Users
Regulatory Affairs Manager, Quality Control Specialist, Compliance Officer, Regulatory Affairs Specialist, Product Development Manager.
Industries Served
Healthcare, Life Sciences, Pharmaceuticals, Medical Devices, Regulatory Affairs
Tags
Compliance, Product Lifecycle Management, Regulatory, Pharmaceutical Industry, Data Management, Regulatory Affairs, Regulatory Compliance, Regulatory Tracking

RegulatoryOne's In-App Market Place

Does RegulatoryOne have an in-app market place?

Yes

How many Mini-Apps in the marketplace?

7

Mini Apps

1. Labeling: Allows users to create

manage

and track product labels to ensure compliance with regulations.

2. Registration Management: Helps with submitting and tracking product registration applications in various regions.

3. Regulatory Intelligence: Provides updates on regulatory changes and requirements to ensure products remain compliant.

4. Submissions Management: Streamlines the process of preparing and submitting regulatory documents to authorities.

5. Quality Management: Assists with managing quality control processes to ensure products meet regulatory standards.

Pricing Options

Free trial
Free version
Request a quote
Promo Offer

Accepted Payment Currencies

USD ($), EUR (€), GBP (£), CAD (C$), AUD (A$), JPY (¥), CHF (CHF), CNY (¥), INR (₹)

Pros & Cons

  • Streamlines regulatory compliance processes
  • Enhances efficiency and accuracy in managing product lifecycle data
  • Helps to ensure compliance with regulations and standards
  • Provides real-time updates and alerts on regulatory changes
  • Improves collaboration and communication among stakeholders in the regulatory process
  • Centralizes all regulatory information and documentation for easy access and retrieval.
  • Steep learning curve for new users
  • Limited customization options
  • Can be expensive for small businesses
  • Incompatibility with certain operating systems
  • Lack of integration with other software systems
  • Slow customer support response time

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