Terms of Service & Testing Agreement

1. Service Engagement & Study Orders

Jarvogen Research Private Limited (“Jarvogen”) performs analytical research, pharmacopoeial testing, stability studies, elemental impurity quantification, nitrosamine assay, and method validation upon receipt of a signed Work Order, Sample Request Form, or written contract from the client (“Sponsor”).

Each study order incorporates pre-defined analytical scopes, target monographs (USP, EP, BP, IP, or validated in-house methods), acceptance criteria, and agreed deliverables.

2. Sample Intake, Packaging & Chain of Custody

The Sponsor is responsible for providing adequately labeled, stable, and safely packaged sample specimens accompanied by relevant Safety Data Sheets (SDS / MSDS) and Certificate of Analysis (CoA) for reference standards.

• Verification: Upon delivery at our Baleshwar City, Ahmedabad facility, samples undergo immediate LIMS barcoding and container integrity inspection within 2 hours.
• Storage: All samples are maintained strictly under sponsor-designated storage (e.g. ambient, 2–8°C, -20°C, or ICH stability chambers).
• Hazardous Materials: Hazardous, radioactive, or cytotoxic compounds must be declared prior to dispatch.

3. Analytical Methods & cGLP Protocol Execution

Testing is executed in strict adherence to cGLP (current Good Laboratory Practice) standards and our FDCA Gujarat State Form 37 approval.

4. Turnaround Times & Priority Testing Slots

Standard turnaround times (TAT) are established in the approved Quotation (typically 5–10 working days for routine QC; 15–30 days for full AMV).

• TAT commences from the date all test samples, reference standards, and required technical paperwork are logged into LIMS.
• Expedited priority testing (24–48 hour turnarounds) is available for urgent batch release upon prior slot reservation.

5. Certificates of Analysis (CoA) & Out of Specification (OOS)

Upon test completion, Jarvogen issues an official, digitally signed Certificate of Analysis (CoA) or comprehensive Analytical Study Dossier backed by 21 CFR Part 11 electronic audit trails.

In the event of an Out-of-Specification (OOS) or atypical analytical result, Jarvogen immediately initiates a formal Phase I laboratory investigation per FDA OOS guidance, including instrument verification, calibration check, and dual-analyst review before notifying the Sponsor.

6. Intellectual Property & Absolute Client Ownership

All intellectual property, formulation matrices, analytical data, chromatograms, spectra, validation dossiers, and research outcomes generated under client sponsorship remain the sole, exclusive property of the Sponsor.

Jarvogen retains ownership only of general laboratory SOPs, generic method templates, and proprietary operational software tooling not specific to the client molecule.

7. Quotations, Pricing & Payment Terms

All pricing is quoted in Indian Rupees (INR) or US Dollars (USD) as specified in the formal Quotation.

• Quotations remain valid for 30 days from the date of issuance.
• Standard commercial payment terms are Net 30 days from the date of invoice issuance, unless otherwise agreed under an active Master Service Agreement.
• Applicable statutory taxes (including GST) are billed in accordance with prevailing Indian tax regulations.

8. Warranties & Limitation of Liability

Jarvogen warrants that all testing services are conducted in good faith with professional scientific diligence, calibrated instrumentation, and certified reference standards in compliance with cGLP and pharmacopoeial guidelines.

To the maximum extent permitted by applicable law, Jarvogen's total aggregate liability arising out of or related to any testing service shall not exceed the total fees paid by the Sponsor for the specific sample or study batch in question. Jarvogen shall not be liable for indirect, consequential, or commercial lost profit damages.

9. Governing Law & Dispute Resolution

These Terms and Conditions shall be governed by, construed, and enforced in accordance with the laws of the Republic of India.