Terms of Service

2.1 Four-Phase Scientific Pipeline

Every prediction flows through four rigorous phases:

2.2 Prediction Capabilities

• Single-API pharmaceutical stability prediction with full kinetic modelling
• Fixed-Dose Combination (FDC) multi-API interaction assessment (new in v7.0)
• ICH Q1A(R2) aligned shelf-life projections across ICH climate zones I–IVb
• ICH Q3B(R2) degradant impurity compliance checking
• ICH M7(R2) genotoxic impurity assessment
• Packaging performance comparison across 10+ container-closure systems
• Regulatory alignment for FDA, EMA, WHO, CDSCO, and TGA submissions

2.3 Deployment Options

PSPS is available as a cloud-hosted SaaS platform or as a self-hosted enterprise deployment. SaaS and self-hosted deployments are subject to these Terms unless a separate enterprise agreement governs the relationship.

3.1 Permitted Uses

You may use PSPS for:

• Pharmaceutical stability screening and shelf-life prediction for drug substances and drug products
• Formulation development: excipient selection, packaging optimisation, and go/no-go decisions
• Design and optimisation of ICH stability study protocols
• Pre-submission regulatory risk assessment and dossier preparation
• Academic research and stability science education
• Processing formulation data for which you hold proper authorization and legal rights

3.2 User Responsibilities

You are responsible for:

• Ensuring accuracy and completeness of all formulation data and API parameters submitted
• Holding proper authorization to submit and process all formulation data provided to PSPS
• Maintaining confidentiality of your account credentials and formulation data
• Verifying and interpreting all stability predictions with qualified pharmaceutical professionals before regulatory use
• Implementing corrective actions or study designs based on qualified professional review of PSPS outputs
• Reporting suspicious activities or security concerns immediately to our support team

3.3 Prohibited Activities

You may not:

• Submit data containing malicious code, security threats, or falsified formulation information
• Process proprietary third-party formulation data without proper authorization or confidentiality agreements
• Attempt to manipulate, reverse-engineer, bypass, or circumvent any PSPS computation engine or security measure
• Share platform access credentials without proper authorization from your organization
• Redistribute, resell, or commercialize PSPS outputs or analysis without written permission
• Use PSPS outputs as a substitute for regulatory-required stability studies without appropriate scientific justification
• Use the platform for any illegal or unauthorized purpose

4.1 System Requirements

To use PSPS optimally, you must maintain:

• Stable high-speed internet connection (minimum 10 Mbps recommended)
• Modern web browsers: Chrome, Firefox, or Safari (latest versions)
• Adequate system memory (minimum 8 GB RAM for optimal performance)

4.2 Data Input Requirements

• Formulation data must be entered accurately; prediction quality is directly dependent on input data quality
• API names, molecular weights, and stability parameters should conform to pharmacopoeial or published reference standards
• For FDC predictions, all API components must be individually specified

4.3 Processing Limitations

• Standard prediction target: under 5 minutes per analysis
• Processing capacity managed to maintain system performance for all users
• Priority processing available during off-peak hours; enterprise SLA available on request

5.1 Security Measures

We implement enterprise-grade security throughout the PSPS platform, including:

• End-to-end encryption for all formulation data in transit and at rest
• Secure, isolated computation environment for each prediction job
• Enterprise-grade access controls and authentication protocols
• Regular security audits, vulnerability assessments, and monitoring

5.2 Zero-Retention Policy

• No storage of processed formulation data or personal submission information beyond active session
• Formulation data and API parameters are never used to train, fine-tune, or improve our AI models
• No data sharing with any third party under any circumstances
• Generated stability reports are provided solely for your download and local storage

5.3 Formulation Confidentiality

• No Company personnel can access your submitted formulation data or its content
• All processing occurs in an isolated, secure computation environment
• Complete confidentiality is maintained throughout the prediction pipeline
• PSPS is designed to be safe for use with proprietary, confidential formulation data

6.1 Special Categories

The following categories of data require enhanced diligence when used with PSPS:

• Formulations intended for paediatric or vulnerable populations
• Narcotics, controlled substances, and Schedule H or H1 drugs
• Biologics, biosimilars, and Advanced Therapy Medicinal Products (ATMPs)
• Formulations subject to ongoing regulatory review or under active patent challenge
• Data subject to trade secret protections or third-party confidentiality obligations

6.2 Additional Requirements

For high-risk or sensitive formulation data, you must:

• Ensure your organization's data governance and IP policies permit submission to external AI platforms
• Have qualified stability scientists or regulatory professionals review all PSPS outputs before use in submissions
• Follow your organization's internal security protocols for handling proprietary formulation data
• Clearly disclose AI-assisted analysis in regulatory submissions as required by applicable guidelines

7.1 AI Assistance Disclosure

• PSPS integrates AI technology in Phase 1 (Literature Research) for API data extraction and parameter synthesis
• Phases 2–4 use deterministic, proprietary computation engines — not generative AI
• All AI-generated literature parameters are validated and cross-checked in Phase 3 before inclusion in reports
• Final stability predictions and report outputs require human interpretation by qualified pharmaceutical professionals
• PSPS serves as a predictive decision-support tool, not an automatic regulatory approval system

7.2 Result Interpretation

• Generated stability reports should be reviewed immediately and transferred to your local systems upon download
• Interpretation must be performed by qualified stability scientists or regulatory affairs professionals within your organization
• PSPS identifies predicted degradation profiles and shelf-life estimates but cannot account for organization-specific manufacturing process variabilities
• Final determination of regulatory strategy and study design must align with your organization's risk assessment framework
• Confidence scores are provided to communicate prediction reliability — results with lower confidence scores require additional experimental verification

7.3 Accuracy and Reliability

• PSPS predictions are grounded in established kinetic science (Arrhenius modelling, ASAP methodology, QSPR) and peer-reviewed pharmaceutical literature
• Prediction accuracy is dependent on the quality and completeness of input data and the availability of published reference data for the API
• Users must evaluate PSPS findings against specific regulatory requirements, internal policies, and applicable pharmacopoeial standards
• Human scientific oversight is required for all regulatory and formulation implementation decisions

8.1 Platform Ownership

The PSPS platform — including all 14 proprietary computation engines, algorithms, software, prediction methodologies, report templates, and related technologies — is owned by Noxie Innovation (OPC) Private Limited and is protected by applicable intellectual property, copyright, and trade secret laws.

8.2 User Formulation Data

• You retain full ownership of all formulation data and API parameters you submit for processing
• You grant us a limited, transient right to process your data solely for the purpose of generating your requested stability prediction during the active session
• You warrant that you hold the necessary rights and authorizations to submit all data for processing

8.3 Generated Reports

• ICH-aligned stability reports generated by PSPS are provided for your exclusive use
• You may use, include, and reference generated reports in regulatory submissions, internal documents, and scientific publications
• You may not redistribute, license, or resell PSPS-generated reports as a standalone product or service without our written permission
• Reports become your property upon download and are not retained by PSPS in accordance with our Zero-Retention Policy

9.1 Service Uptime

We strive to maintain high service availability. However, we cannot guarantee 100% uptime due to:

• Scheduled maintenance and platform updates
• Computation engine version upgrades (e.g., engine additions, model improvements)
• Unforeseen technical issues or infrastructure failures
• Third-party service dependencies (cloud providers, data sources)

9.2 Maintenance Windows

• Scheduled maintenance will be announced in advance where possible
• Emergency maintenance or critical security updates may occur without prior notice
• New engine versions (e.g., v7.0 E14 API Interaction Assessor) may be deployed with a versioning notice on the platform

10.1 Service Fees

• Pricing is published on our website and may vary based on plan type, prediction volume, and deployment model (SaaS or self-hosted)
• All fees are non-refundable unless otherwise specified in our Refund Policy
• Enterprise pricing and custom SLA arrangements are available — contact us for details

10.2 Payment Processing

• Payment is required before platform access is granted
• Accepted payment methods are specified during registration and checkout
• Automatic billing applies to subscription plans where applicable

11.1 Predictive Tool Limitation

11.2 Disclaimer of Warranties

11.3 Limitation of Damages

13.1 Termination by User

You may terminate your PSPS account at any time by discontinuing use of our services and deleting your account through our platform settings.

13.2 Termination by Company

We may suspend or terminate your access immediately for:

• Violation of these Terms or our acceptable use policies
• Suspected fraudulent, illegal, or abusive activity
• Non-payment of fees
• Breach of security protocols or unauthorized use of credentials

13.3 Effect of Termination

• Your access to the PSPS platform will cease immediately upon termination
• All pending prediction jobs will be completed or cancelled at our discretion
• Data deletion will occur according to our Zero-Retention Policy — no formulation data is stored beyond active sessions
• No refunds will be provided except as specified in our Refund Policy

15.1 Governing Law

These Terms shall be governed by and construed in accordance with the laws of India, without regard to conflict of law principles.

15.2 Jurisdiction

Any disputes arising under these Terms shall be subject to the exclusive jurisdiction of the courts in Ahmedabad, Gujarat, India.

15.3 Alternative Dispute Resolution

Before filing any legal action, both parties agree to attempt resolution through good faith negotiation for a period of 30 days from the date the dispute is first raised in writing.

17.1 Terms Updates

We reserve the right to modify these Terms at any time. Changes will be effective upon posting to our website with an updated effective date.

17.2 Notification of Changes

• Material changes will be communicated via email or platform notification
• Continued use of PSPS after changes constitutes acceptance of the modified Terms
• If you disagree with changes, you must discontinue use of our services

17.3 Platform Updates

We may update, modify, or add computation engines and features at any time. Version updates (e.g., addition of Engine E14 for FDC in v7.0) will be communicated via platform release notes.

18 Severability

If any provision of these Terms is found to be invalid, illegal, or unenforceable by a court of competent jurisdiction, the remaining provisions shall continue in full force and effect.

19 Entire Agreement

These Terms, together with our Privacy Policy and any other policies referenced herein (including any enterprise agreement in effect), constitute the entire agreement between you and Noxie Innovation (OPC) Private Limited regarding use of PSPS.

20 Waiver

Failure by either party to enforce any provision of these Terms shall not constitute a waiver of that party's right to enforce such provision at any time.

• "PSPS" means the Pharmaceutical Stability Prediction System, an AI-powered kinetic modelling and stability prediction platform operated by Noxie Innovation (OPC) Private Limited.
• "Computation Engines" means the 14 proprietary deterministic algorithms within PSPS that perform kinetic analysis, environmental corrections, packaging assessment, excipient scoring, confidence scoring, and shelf-life projection.
• "Stability Prediction" means the AI- and engine-generated output of PSPS, comprising shelf-life estimates, degradation profiles, confidence scores, and ICH compliance assessments.
• "ICH-Aligned Report" means the 18-section stability report generated by PSPS in accordance with ICH Q1A(R2), Q3B(R2), and M7(R2) guidelines.
• "Zero-Retention Policy" means PSPS's practice of automatically and permanently deleting all formulation data, API parameters, and user-submitted inputs upon completion of each prediction session.
• "FDC" means Fixed-Dose Combination — a pharmaceutical product containing two or more active pharmaceutical ingredients in a single dosage form.
• "Qualified Professional" means a stability scientist, formulation scientist, regulatory affairs professional, or other suitably qualified person responsible for interpreting and acting upon PSPS outputs.
• "High-Risk Data" means formulation data for controlled substances, paediatric medicines, biologics, ATMPs, or data subject to trade secret or third-party confidentiality obligations.
• "Acceptable Use" means legitimate use of PSPS for pharmaceutical stability prediction, formulation development, regulatory decision-support, and academic research, with proper authorization for all data submitted.