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Terms of Service

Last Updated: February 2025

Agreement to Terms

These Terms of Service ("Terms") govern your use of the Rizents International website and services. By accessing our website or engaging our services, you agree to be bound by these Terms. If you do not agree to these Terms, please do not use our website or services.

Rizents International provides clinical research support, regulatory writing, pharmacovigilance, medical writing, and quality compliance services to pharmaceutical, biotechnology, medical device, and healthcare organizations.

Services Description

Rizents International offers the following services:

Clinical Research Services

  • • Clinical trial planning and support
  • • Protocol development
  • • Clinical study reports
  • • TMF documentation

Regulatory Affairs

  • • IND/NDA/BLA documentation
  • • CTD/eCTD preparation
  • • Regulatory response documents
  • • Risk Management Plans

Pharmacovigilance

  • • Safety narratives
  • • DSUR/PSUR/PBRER
  • • Signal detection reports
  • • Benefit-risk assessments

Medical Writing

  • • Manuscripts and publications
  • • Literature reviews
  • • Scientific presentations
  • • White papers

Service Engagement Terms

1. Proposals and Agreements

All services are provided pursuant to written proposals, statements of work, or master service agreements. These documents specify the scope, deliverables, timelines, and fees for each engagement. No services will commence until both parties have executed the applicable agreement.

2. Client Responsibilities

Clients are responsible for:

  • Providing accurate and complete information necessary for service delivery
  • Timely review and approval of deliverables
  • Designating authorized representatives for project communications
  • Payment of fees in accordance with agreed terms
  • Compliance with applicable laws and regulations

3. Deliverables and Acceptance

Deliverables will be provided in accordance with the specifications outlined in the applicable agreement. Clients shall have a reasonable period to review deliverables and provide feedback. Deliverables are deemed accepted unless written objections are received within the agreed review period.

4. Fees and Payment

Fees for services are specified in the applicable agreement. Unless otherwise agreed, invoices are payable within 30 days of receipt. Late payments may be subject to interest charges and/or suspension of services.

Intellectual Property

Client Materials: All materials, data, and information provided by clients remain the property of the client.

Deliverables: Upon full payment, clients receive ownership of deliverables specifically created for them under the applicable agreement, except for Rizents International's pre-existing intellectual property, tools, methodologies, and know-how.

Rizents International Property: All proprietary tools, templates, methodologies, processes, and general know-how developed or used by Rizents International remain our exclusive property.

Confidentiality

Both parties agree to maintain the confidentiality of proprietary and confidential information disclosed during the engagement. Our detailed confidentiality practices are described in our Confidentiality Statement. Specific confidentiality obligations may be set forth in the applicable service agreement.

Warranties and Disclaimers

Service Warranty: Rizents International warrants that services will be performed in a professional and workmanlike manner consistent with industry standards.

No Regulatory Guarantee: While we provide high-quality regulatory documentation and support, we cannot guarantee the approval of any regulatory submission. Regulatory decisions are made solely by the applicable regulatory authorities.

DISCLAIMER: EXCEPT AS EXPRESSLY SET FORTH HEREIN, ALL SERVICES ARE PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.

Limitation of Liability

To the maximum extent permitted by law:

  • Rizents International shall not be liable for any indirect, incidental, special, consequential, or punitive damages
  • Our total liability for any claim shall not exceed the fees paid for the specific services giving rise to the claim
  • These limitations apply regardless of the theory of liability (contract, tort, strict liability, or otherwise)

Some jurisdictions do not allow the exclusion or limitation of certain damages, so these limitations may not apply to you.

Indemnification

Clients agree to indemnify, defend, and hold harmless Rizents International and its officers, directors, employees, and agents from and against any claims, damages, losses, and expenses (including reasonable attorneys' fees) arising from:

  • Client's breach of these Terms or any service agreement
  • Client's violation of any law or regulation
  • Client's use of deliverables
  • Any third-party claims related to client's products or services

Term and Termination

The term and termination provisions for each engagement are specified in the applicable service agreement. Generally:

  • Either party may terminate for material breach upon written notice and failure to cure within a specified period
  • Termination does not affect obligations that have accrued prior to termination
  • Confidentiality obligations survive termination
  • Upon termination, clients shall pay for all services rendered and expenses incurred through the termination date

Governing Law and Dispute Resolution

These Terms shall be governed by and construed in accordance with the laws of India. Any disputes arising from these Terms or our services shall be resolved through good-faith negotiations. If negotiations fail, disputes shall be submitted to binding arbitration or the courts of competent jurisdiction as specified in the applicable service agreement.

Important Notice

Rizents International provides scientific, clinical, and regulatory support services and does not act as a legal representative before regulatory authorities. Our services are advisory and support in nature. Clients remain responsible for all regulatory submissions and interactions with regulatory authorities.

Modifications to Terms

We reserve the right to modify these Terms at any time. Changes will be effective upon posting to our website. Your continued use of our website or services after any changes constitutes acceptance of the modified Terms. We encourage you to review these Terms periodically.

Contact Us

If you have questions about these Terms of Service, please contact us:

Rizents International

Email: rizentsinternational@gmail.com

Phone: +91 8130673717