Precision Analytical Testing & cGLP Research Lab
End-to-end contract analytical testing for pharmaceuticals, APIs, formulations, and packaging materials. Data generated for USFDA, EMA, and global regulatory submissions under strict ALCOA+ data integrity.
Comprehensive Testing Solutions
All 12 cGLP-compliant analytical testing disciplines housed under one roof at our Baleshwar City, Ahmedabad facility.
Pharmaceutical Testing
Complete testing of APIs, formulations, excipients & finished products per USP, EP, BP, IP, and ICH guidelines.
E&L Studies
Drug-container interaction assessment using LC-MS/MS, GC-MS, and ICP-MS. Data accepted by US & EU regulators.
Stability Studies
ICH-compliant long-term, accelerated, and stress stability testing with 24/7 monitored climatic chambers.
Elemental Impurities
ICH Q3D & USP <232>/<233> testing of 24 elemental impurities using ICP-OES and sub-ppb ICP-MS.
Nitrosamine & NDSRI Testing
Trace detection of NDMA, NDEA and drug substance-related nitrosamines (NDSRIs) via high-res LC-MS/MS.
IVRT & IVPT Studies
In-Vitro Release & Permeation Testing for topical generic formulations using automated Franz diffusion cells.
Dissolution Profiling
Comparative dissolution profiling (CDP), multimedia curves (pH 1.2, 4.5, 6.8) and f2 similarity calculations.
Method Development & Validation
Stability-indicating assays, residual solvents, and dissolution method validation compliant with ICH Q2(R2).
Residual Solvent Testing
Headspace GC-FID/MS testing for Class 1, 2, and 3 volatile organic solvents per USP <467> and ICH Q3C.
Physico-Chemical Analysis
Comprehensive wet chemistry, titrimetry, Karl Fischer moisture, optical rotation, and pharmacopoeial assays.
Pharma Water Analysis
Chemical purity, conductivity, heavy metals, and TOC testing for Purified Water, WFI, and process systems.
Cleaning Method Validation
Analytical method development and swab/rinse residue testing to verify equipment cleanliness per FDA cGMP.
Meet our scientific leadership
Directors with deep analytical, commercial, and operations experience across leading Indian pharma companies.
Dr. Rajesh Desai
Director · Business Development
Core Industry Expertise
- Founder of Molsyns Research (impurity synthesis and characterisation)
- Method development, validation, and characterisation
Industry Experience
Dr. Vijay Patel
Director · Techno Commercial
Core Industry Expertise
- 15+ years in analytical development and validation
- E&L, nitrosamines, and product characterisation
Industry Experience
Mr. Jay Patel
Director · Operations
Core Industry Expertise
- 15+ years in analytical development and validation
- Analytical method development, validation, and routine testing
Industry Experience
From Sample Receipt to Certified CoA
Our streamlined 5-stage laboratory execution ensures complete traceability, regulatory compliance, and rapid turnaround on every batch.
Sample Intake & LIMS Login
Sample logged into LIMS with unique barcode, storage conditions assigned, and physical integrity verified within 2 hours.
Protocol & Method Assignment
Senior scientist selects validated compendial (USP/EP/IP) or customized ICH Q2(R1) protocol with pre-approved analytical plan.
High-Precision cGLP Testing
Analysis performed in duplicate on calibrated HPLC, LCMS/MS, GC-MS, or ICP-MS instruments with 21 CFR Part 11 electronic capture.
4-Eye QC & Data Review
Dual-analyst verification of raw chromatograms, baseline integrations, calibration curves, and system suitability parameters.
Signed CoA & Dossier Release
Official Certificate of Analysis issued digitally with raw data backup, LIMS electronic signature, and regulatory submission support.
Standard & Priority Turnaround Options
Standard studies delivered in 5–10 working days. Urgent batch release slots available in 24–48 hours upon reservation.
Official Regulatory Licensure & Approvals
All analytical testing operations at Jarvogen are conducted in full compliance with the Drugs & Cosmetics Act and our active FDCA Gujarat State Form 37 approval.
FDCA Gujarat State Form 37 Approval
Food & Drugs Control Administration, Gujarat State, India
Official statutory approval for commercial pharmaceutical testing, Active Pharmaceutical Ingredients, drug formulations, and excipients.
Ready to Begin
Analytical Testing?
Submit your sample or request a quote - our scientific team responds within 24 hours. Regulatory data accepted by USFDA & EMA.