Privacy Policy & Data Protection

1. Introduction & Scope of Policy

Jarvogen Research Private Limited operates a specialized contract analytical research laboratory located at A-306, Baleshwar City, Opp. Dharamvatika Complex, Hathijan Circle, Ahmedabad – 382445, Gujarat, India.

This Privacy Policy describes how we collect, handle, store, protect, and process proprietary technical information, sponsor documentation, sample matrices, analytical raw data, and personal data through our website (jarvogen.com), client submission portals, and laboratory operations.

2. Client Intellectual Property & NDA Confidentiality

Prior to receiving any physical samples, testing protocols, or analytical method specifications, Jarvogen routinely executes bilateral Non-Disclosure Agreements (NDAs) with client sponsors.

• No Commercial Exploitation: Jarvogen never commercializes, reverse-engineers, shares, or licenses proprietary client formulations or synthesis routes.
• Access Control: Access to study data is strictly limited to authorized doctoral scientists and QC reviewers directly assigned to the respective study code.
• Physical Security: Samples and analytical standard references are stored in climate-monitored, badge-restricted repository vaults.

3. 21 CFR Part 11 & ALCOA+ Data Integrity Standards

All computerized analytical systems at Jarvogen (including Waters Empower 3 and Agilent ChemStation) are fully validated in compliance with USFDA 21 CFR Part 11 and EU Annex 11 regulations:

4. Information We Collect

We collect information provided directly by clients and website visitors through:

• Sample Intake & RFP Forms: Organization name, authorized scientist contact, email, phone, sample batch IDs, storage specifications, and target pharmacopoeia monographs.
• Technical Communications: Protocol customization requirements, forced degradation parameters, and method validation acceptance criteria.
• Technical Website Data: Anonymized server logs, IP addresses, browser types, and session telemetry used strictly to ensure site availability and prevent unauthorized penetration attempts.

5. How We Use Client Information

Information provided is utilized exclusively to:

• Execute commissioned testing, analytical method development (AMD), and validation (AMV) studies.
• Generate official Certificates of Analysis (CoAs) and regulatory filing dossiers.
• Communicate study milestones, intermediate pull results, and quality control updates.
• Comply with statutory recordkeeping under our FDCA Gujarat State Form 37 approval and cGLP guidelines.

6. Regulatory Audits & Authorized Disclosures

Jarvogen never sells, rents, or trades client data to third parties. Disclosure of study data occurs solely under the following authorized circumstances:

• Direct Client Authorization: Upon written request by the contracting sponsor to submit data packets directly to regulatory bodies (e.g. USFDA, EMA, MHRA, CDSCO).
• Statutory Inspections: During official cGLP / Form 37 compliance audits conducted by authorized inspectors from the Food and Drugs Control Administration (FDCA), where raw data verification is legally mandated.

7. Data Retention & Archival Policies

In adherence to cGLP and pharmacopoeial retention standards:

• Raw analytical data files, instrument sequence logs, and signed CoAs are retained in secure, read-only digital archives for a minimum of 5 years following study completion (or longer as specified by sponsor contract).
• Physical sample retention reserves are stored in temperature-controlled chambers until the agreed disposal or return timeline.

8. Sponsor Rights & Data Access

Client sponsors maintain full rights to:

• Request copies of full raw data sets, chromatograms, and calibration curves.
• Audit study records and validation dossiers with reasonable advance notice.
• Request secure return or verified certificate of destruction for excess sample matrices upon study conclusion.

9. Contact Our Data Protection Officer (DPO)

For questions regarding data privacy, confidentiality agreements, or ALCOA+ compliance procedures, please contact our Quality Assurance & Data Protection Office: