Official Regulatory Credentials • FDCA Gujarat State Registered

State Licensure & Regulatory Accreditations

Verified statutory certifications, cGLP quality compliance frameworks, 21 CFR Part 11 electronic data governance, and international pharmacopoeial alignment for global pharmaceutical testing.

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Form 37
Official Approval
FDCA Gujarat commercial testing license
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100%
cGLP Compliance
Independent QA Unit oversight
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21 CFR Part 11
Data Integrity
Enforced audit trails & electronic signatures
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0
Regulatory Actions
Impeccable compliance standing
Accreditation Standards:
FDCA Gujarat State Authority
Form 37 Commercial Approval
cGLP Governed
21 CFR Part 11 Compliant
USP/EP/BP/IP Guidelines
Primary Statutory License

FDCA Gujarat State Certification

Jarvogen operates under an active commercial testing license granted by the Food and Drugs Control Administration (FDCA), Gujarat State - supporting regulated pharmaceutical operations.

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✓ Certificate Valid
Statutory Certification

FDCA Gujarat State Testing Laboratory License

Form 37 Commercial Approval

Food and Drugs Control Administration, Gujarat State • Ahmedabad, Gujarat, India

Authorized Regulatory Scope:

Authorized commercial testing and analysis of Drugs, Active Pharmaceutical Ingredients (APIs), Finished Formulations, Excipients, and Packaging Materials under the Drugs and Cosmetics Act.

Key Certification Attributes:

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Official Form 37 approval for commercial analytical testing
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Full spectrum chromatographic, spectroscopic & microbiological assays
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Covering APIs, oral solids, topicals, parentals, and packaging
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Accepted by leading Indian & multinational pharmaceutical sponsors
Contact QA for Audit Scheduling →
Compliance Matrix

Regulatory Governance Pillars

Explore the four statutory and operational compliance frameworks ensuring global data acceptance.

🏛️State Licensure Framework

FDCA Gujarat State Statutory Certification

Operating as a licensed public testing laboratory under the Drugs and Cosmetics Act and Rules, compliant with Schedule L1 requirements.

01Statutory Authority

Form 37 Commercial License

Formal authorization issued by the State Drugs Controller for commercial batch release and regulatory analytical testing.

Verified Compliance Standard
02Full Compendia

Authorized Analytical Scope

Assay, related substances, residual solvents, heavy metals, elemental impurities (ICP-MS), dissolution, and E&L.

Verified Compliance Standard
03Approved Personnel

Approved Technical Staff

All senior analysts and section heads individually approved by the regulatory authority based on qualifications.

Verified Compliance Standard
Form 37 Scope Matrix

Authorized Testing Capabilities

Analytical disciplines licensed under our FDCA Gujarat State approval across pharmaceutical product lifecycles.

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Active Pharmaceutical Ingredients (APIs)

•Identification & Assay by HPLC/UV/Titration
•Related Substances & Organic Impurities
•Class 1, 2, 3 Residual Solvents by Headspace GC
•ICH Q3D Elemental Impurities by ICP-MS
•Trace Nitrosamines (NDMA, NDEA, NDSRIs)
Licensed Parameter
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Finished Dosage Forms & Formulations

•Dissolution Profiling (USP I, II & IV) & f2 Similarity
•Uniformity of Dosage Units & Assay
•Degradation Products & Forced Degradation
•In-Vitro Release (IVRT) & Permeation (IVPT) for Topicals
•Finished Product Release Testing
Licensed Parameter
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Packaging & Container Closure Systems

•Extractable & Leachable (E&L) Studies (USP <1663>/<1664>)
•Organic Volatiles & Semi-Volatiles by GC-MS
•Non-Volatile Extractables by LC-MS/MS
•Inorganic / Elemental Leachables by ICP-MS
•Toxicological Safety Evaluation (AET / SCT / TTC)
Licensed Parameter
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Pharmaceutical Water & Environmental

•Purified Water Testing (USP <645> / EP / IP)
•Water for Injection (WFI) Chemical & TOC Testing
•Total Organic Carbon (TOC) per USP <643>
•Conductivity, Heavy Metals & Anion Profiling
•Cleaning Validation Swab & Rinse Analysis
Licensed Parameter
Audit Coordination

Ready to Initiate Vendor Qualification?

Our QA team will provide certified license copies, Site Master File summaries, and complete audit support.

Schedule Regulatory Audit