Privacy Policy

Section 01

Overview

Orionex Regulatory Solutions (a division of Orionex Trading LLC, "we", "us", or "our") is committed to protecting your privacy. This Privacy Policy explains how we collect, use, disclose, and safeguard your information when you visit our website at www.orionexregulatory.com or use our FDA regulatory consulting services.

Orionex Trading LLC acts as the data controller for the personal information collected through this website and our services. As data controller, we determine the purposes and means by which your personal data is processed.

We process personal data based on contractual necessity (to deliver services you have engaged us for), legal obligations (to comply with applicable laws and regulations), and legitimate business interests (to operate and improve our services). Full details of our lawful bases are set out in Section 10.

By using our website or services, you consent to the practices described in this Privacy Policy. If you disagree with any part of this policy, please do not use our services.

Section 02

Information We Collect

Information You Provide Directly

When you contact us, submit a form, or purchase our services, we may collect:

Data Type	Examples	Purpose
Identity Data	First name, last name, job title	Account management, correspondence
Contact Data	Email address, phone number	Service delivery, support
Company Data	Company name, address, country	FDA registration submissions
Regulatory Data	Product information, facility details, FEI numbers	FDA submission requirements
Payment Data	Billing address (card details processed by Stripe/PayPal)	Payment processing
Communication Data	Emails, messages, notes	Service delivery, record keeping

Information Collected Automatically

When you visit our website, we may automatically collect technical data including your IP address, browser type and version, pages visited, time and date of visit, and referring website. This data is collected via cookies and similar technologies (see Section 5).

Section 03

How We Use Your Information

We use the information we collect for the following purposes:

• Service Delivery — To process your FDA registration submissions, act as your U.S. Agent, and fulfill all contracted services
• Communication — To respond to inquiries, provide service updates, and send important regulatory reminders (e.g., annual renewal notices)
• Payment Processing — To process transactions and prevent fraudulent activity
• Legal Compliance — To comply with applicable laws, regulations, and legal processes
• Service Improvement — To analyze how our website is used and improve our content and services
• Marketing — To send you relevant information about our services, where you have consented or where permitted by law (you may opt out at any time)

We will only use your personal data for the purposes for which it was collected, unless we reasonably determine that we need to use it for another reason compatible with the original purpose.

Section 04

Information Sharing

We do not sell, trade, or rent your personal information. We may share your information only in the following circumstances:

With the FDA

To perform our services, we submit required information to the U.S. Food and Drug Administration on your behalf. This is the core function of our U.S. Agent and registration services.

With Service Providers

We may share data with trusted third-party service providers who assist us in operating our website and delivering services, including payment processors (Stripe, PayPal), email platforms, and cloud storage. These parties are contractually bound to protect your data and may only use it for specified purposes.

Legal Requirements

We may disclose your information if required to do so by law, court order, or government authority, or if we believe disclosure is necessary to protect our rights, your safety, or the safety of others.

Business Transfers

In the event of a merger, acquisition, or sale of assets, your information may be transferred as part of that transaction. We will notify affected users via email or prominent notice on our website.

Section 05

Cookies & Tracking Technologies

Our website uses cookies and similar tracking technologies to enhance your browsing experience and analyze site traffic. We use the following types of cookies:

• Essential Cookies — Required for the website to function properly. These cannot be disabled.
• Analytics Cookies — Help us understand how visitors interact with our website (e.g., Google Analytics). Data is anonymized and aggregated. These are only activated upon your consent.
• Preference Cookies — Remember your settings and preferences to improve your experience on return visits.

When you first visit our website, a cookie consent banner will ask for your permission before any non-essential cookies are set. You may accept all cookies, reject non-essential cookies, or manage your preferences at any time.

You can also control cookies through your browser settings at any time. Note that disabling certain cookies may affect the functionality of our website.

Section 06

Payment Data

All payment transactions are processed securely by Stripe and PayPal — industry-leading PCI-compliant payment processors. Orionex does not store, process, or have access to your full credit card numbers or payment credentials.

We retain billing address information and transaction records for accounting, tax compliance, and fraud prevention purposes in accordance with applicable law.

Please review Stripe's Privacy Policy (stripe.com/privacy) and PayPal's Privacy Statement for details on how they handle your payment data.

Section 07

Data Retention

We retain personal information for as long as necessary to fulfill the purposes outlined in this policy, or as required by law. Specifically:

• Client records and regulatory submissions — Retained for a minimum of 7 years to comply with business and legal obligations
• Contact and inquiry data — Retained for 2 years after last contact, unless converted to a client relationship
• Payment records — Retained for 7 years for tax and accounting compliance
• Website analytics data — Retained in anonymized form for up to 26 months

When data is no longer required, we securely delete or anonymize it in accordance with our data disposal procedures.

Section 08

Data Security

We implement appropriate technical and organizational measures to protect your personal information against unauthorized access, alteration, disclosure, or destruction. These measures include:

• SSL/TLS encryption for all data transmitted to and from our website
• Secure, access-controlled storage of client files and regulatory documents
• Regular review and updating of our security practices
• Limiting access to personal data to employees and contractors who need it to perform their job

While we strive to use commercially acceptable means to protect your information, no method of transmission over the Internet is 100% secure. We cannot guarantee absolute security but are committed to protecting your data to the best of our ability.

Section 09

Your Rights

Depending on your location, you may have the following rights regarding your personal data:

To exercise any of these rights, please contact us at info@orionexregulatory.com. We will respond within 30 days. We may need to verify your identity before processing your request.

Section 10

GDPR & International Users

If you are located in the European Economic Area (EEA), United Kingdom, or other jurisdictions with data protection laws, additional rights and protections may apply to you under the General Data Protection Regulation (GDPR) or equivalent legislation.

Our lawful basis for processing your personal data includes:

• Contract performance — Processing necessary to deliver our services to you
• Legitimate interests — For website analytics and service improvement
• Legal obligation — Where we are required to process data by law
• Consent — For marketing communications (you may withdraw consent at any time)

By using our services, you acknowledge that your data may be transferred to and processed in the United States. We ensure appropriate safeguards are in place for such transfers.

Section 11

Children's Privacy

Our services are intended for business use by adults (18 years and older). We do not knowingly collect personal information from children under the age of 13. If we become aware that we have inadvertently collected personal data from a child, we will take steps to delete that information promptly.

If you believe a child has provided us with personal information, please contact us immediately at info@orionexregulatory.com.

Section 12

Third-Party Links

Our website may contain links to third-party websites, including the FDA's official website (fda.gov), payment processors, and regulatory resources. These sites have their own privacy policies which we do not control and are not responsible for.

We encourage you to review the privacy policy of any third-party site you visit through links on our website.

Section 13

Changes to This Policy

We may update this Privacy Policy from time to time to reflect changes in our practices, technology, legal requirements, or other factors. When we do, we will update the "Last Updated" date at the top of this page.

For significant changes, we will notify active clients via email. We encourage you to review this policy periodically to stay informed about how we protect your information.

Section 14

Contact Us

If you have any questions, concerns, or requests regarding this Privacy Policy or our data practices, please contact our Data Privacy team:

• Company: Orionex Trading LLC (d/b/a Orionex Regulatory Solutions)
• Address: 2240 E 12th Street, Suite 72, Casper, WY 82609, USA
• Email: info@orionexregulatory.com
• Phone: (307) 441-8160
• Hours: Monday – Friday, 8:00 AM – 6:00 PM MT

We take all privacy inquiries seriously and will respond within 5 business days.