Intertek Pharmaceutical Contract Testing Lab, India

Intertek Pharmaceutical Services India is a leading cGMP-compliant analytical contract testing laboratory in Mumbai, delivering analytical expertise for over 15 years to the global pharmaceutical and chemical industry. Our Intertek lab Mumbai facility is US FDA Audited, NABL Accredited as per ISO/IEC 17025:2017, GLP Certified by Maharashtra FDA, ensuring globally accepted data integrity and regulatory compliance.

Our experts in laboratory testing services in India support pharmaceutical companies across India and worldwide in accelerating drug development, manufacturing, quality control, and market release, while maintaining the highest standards of scientific and regulatory excellence.

Why Partner with Intertek Pharmaceutical Services India

• Globally Accredited Quality Systems — US FDA approved analytical labs in Mumbai, MH-FDA approved, CDSCO compliant, GLP certified, NABL accredited. All instruments are 21 CFR Part 11 compliant.
• Comprehensive Pharmaceutical Testing Solutions — End-to-end support across analytical testing, extractables & leachables, nitrosamine analysis, stability studies, elemental impurities, product & process safety.
• Over 15 Years of Regulatory & Scientific Expertise — Our pharmaceutical laboratory India is trusted by major national and international pharmaceutical and chemical companies for regulated-market analytical support and compliance-driven testing.
• Advanced Analytical Technology Platform — Our analytical laboratories in India have a broad scope of instrumentation. The Intertek Laboratory Mumbai has LC-MS/MS, GC-MS/MS, GC-MS/MS TQD, ICP-MS, Ion Chromatography, HPLC, FTIR and more.
• Global Regulatory & Technical Support Network — Backed by Intertek’s international GXP laboratory network and scientific experts supporting product development, manufacturing, regulatory submissions, and accelerated market release.

Pharmaceutical Analytical Testing Services in India 

Intertek is a trusted pharmaceutical research laboratory India partner, delivering advanced analytical testing, regulatory support, and scientific expertise to pharmaceutical and biopharmaceutical companies across India and global markets. At our analytical labs in Mumbai, we provide a full spectrum of pharmaceutical analytical testing services using advanced instrumentation and validated methodologies aligned with global pharmacopoeias and ICH guidelines.

Our core Intertek Lab Mumbai capabilities include:

• Method Development & Method Validation
• Extractables & Leachables Studies for packaging systems
• Nitrosamine and Genotoxic Impurity Testing (LC-MS/MS & GC-MS/MS)
• Impurity Identification by NIST library
• Glass Delamination and Container Closure Studies
• Batch Release Testing (API & Finished Dosage Forms)
• Anions and Cations [AK1.1]analysis in pharmaceuticals drug product by Ion chromatography
• GMP Pharmaceutical Batch Release Testing for Assay, Dissolution, RS, and more
• Residual Solvent Analysis (GC-MS/GC-HS-MS)
• Elemental Impurity Testing as per ICH Q3D (ICP-MS)
• Dissolution and Disintegration Testing (USP Apparatus I & II)
• Stability Studies (ICH Q1A/Q1B compliant)
• Raw Material Testing for Pharma, Food, and Chemical Industries

Focus on Extractables and Leachables at Intertek India Mumbai

• Leading provider of extractables and leachables testing in India, supporting pharmaceutical, biopharmaceutical, and medical device companies.
• Extensive experience conducting hundreds of E&L studies across inhalation, parenteral, ophthalmic, oral, transdermal, biologic, and drug-device combination products.
• Our Intertek Laboratory Mumbai has a proven track record supporting global regulatory submissions support and compliance with US FDA, EMA, USP <1663>/<1664>, PQRI, and ICH expectations.
• Advanced analytical capabilities using LC-MS/MS, GC-MS/MS, ICP-MS, HPLC, FTIR, and Ion Chromatography for trace-level compound detection and characterization.
• ICH-compliant stability storage facilities enabling comprehensive evaluation of compounds migrating from packaging, container closure systems, and device components.
• Container closure evaluation and medical device leachables testing (ISO 10993-18)[AK2.1]
• Robust study design focused on the detection, identification, quantification, and characterization of volatile/semi-volatile/non-volatile organic and elemental extractables, leachables, and degradation products.
• 21 CFR Part 11 compliant laboratory systems with full audit trails, delivering high-quality analytical data to support patient safety and regulatory confidence.

Pharmaceutical Safety & Process Hazard Testing Services

In addition to our analytical testing labs in Mumbai, Intertek provides specialised process safety and thermal hazard evaluation services to support R&D and manufacturing safety. These services help pharmaceutical manufacturers mitigate risks in API handling, powder processing, and large-scale production environments.

Dust and powder explosivity and ignition tests:

• Combustible Dust Screening Test (in Modified Hartmann Tube): Go/No Go Test
• Minimum Ignition Energy (MIE), ASTM ASTM E-2019-99/VDI 2263 Part 1
• Burning Test or Combustible Test
• Minimum Auto-ignition temperature of dust clouds and Dust Layer.
• Dust Lower Explosivity Limit (LEL) or Minimum Explosible Concentration ( MEC)
• Maximum Explosion Over-pressure (Pmax)
• Dust Specific Characteristic / Dust Severity Test (Kst)
• Limiting Oxygen Concentration (LOC)

Process safety and thermal stability testing:

• Reaction Calorimeter (RC1e)
  • Kinetic reaction data
  • Thermodynamic reaction data
• Thermal Stability data, from Differential Scanning Calorimetry (DSC)
• Thermal Stability indices, using Accelerating Rate Calorimetry (ARC®)
• Certification: NABL Accredited

GMP Audits, Vendor Qualification & Compliance Services

Intertek India also offers pharmaceutical GMP auditing and inspection services, helping clients strengthen their quality systems and supply chain compliance.
We provide:

• GMP Audits as per 21 CFR 210 & 211
• Supplier and Vendor Qualification Audits
• Quality System Gap Assessments
• Regulatory Inspection Readiness Support
• GLP Compliance Audits

Our auditors are internationally trained and experienced in supporting regulatory expectations across USFDA, EMA, MHRA, and CDSCO frameworks.

With a global network including laboratories in India and Switzerland, UK, USA, China and Australia, Intertek provides scientific depth and regulatory credibility. Our Intertek laboratory Mumbai provides leading pharmaceutical industry laboratory India support for pharmaceutical and chemical companies across complex analytical problem solving, regulatory submission support, impurity identification, method development/validation and transfer. 

Whether you are developing a new drug product, scaling up manufacturing, or ensuring global regulatory compliance, Intertek Pharmaceutical Services India provides the analytical expertise and regulatory assurance you need.