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Analytical Services

DMF Filing Support

We offer complete analytical support for Drug Master File (DMF) preparation and submission, including:

Method development and validation data
Stability and impurity profiling
Regulatory-compliant documentation
Ongoing technical support during regulatory review

Analytical Method Development & Validation

We provide method development and validation services in compliance with ICH and FDA guidelines.

Development of analytical methods for APIs, intermediates, impurities, and formulations
Preparation of method validation protocols
Execution of validation studies as per ICH Q2(R1) requirements
Generation of complete validation reports suitable for regulatory submissions

Method Transfer & Analytical Problem Solving

We support method transfer and troubleshooting activities for both pharmacopoeial and non-pharmacopoeial methods.

Transfer of validated pharmacopoeial methods to client laboratories
In-house development of analytical methods for unknown or non-pharmacopoeial compounds
Literature-based and customer-reference method development
Vendor qualification support (MOU basis)

Analytical Problem Solving Includes:

Identification and characterization of unknown peaks
Method evaluation with excipients, formulations, or process-related samples
Investigation of simpler, faster, and robust analytical alternatives
Support for process development, scale-up, and manufacturing troubleshooting

Certificate of Analysis (CoA)

All products supplied by Globesynth Pharma Tech are fully characterized and delivered with a Certified Certificate of Analysis (CoA).

Each CoA is supported by comprehensive analytical data and undergoes R&D Head and Technical QC review prior to release.

Standard CoA Includes:

FT-IR
HPLC / GC Purity
¹H NMR
Mass Spectrometry (MS)

Customized Analytical Reports (On Request)

We also offer tailored analytical packages to meet specific customer and regulatory requirements, including:

Chiral Purity
LC–MS
Potency
Thermogravimetric Analysis (TGA)
Loss on Drying (LOD) / Moisture Content
¹³C NMR (CMR)
2D NMR: COSY, HSQC / HMQC
Residual Solvents

Specific Optical Rotation (SOR)
Elemental Analysis (C, H, N)
Halide Content by Ion Chromatography (IC)
Capillary Electrophoresis (CE Purity)
Preparative HPLC (Impurity separation & purification)

Advanced Analytical Capabilities

We specialize in high-precision analytical services, including:

Mass Spectrometry
LC–MS Analysis
HPLC Analysis
Preparative HPLC Purification

Our advanced instrumentation and experienced analytical scientists ensure accurate, reproducible, and regulatory-compliant results.

Specialized Compliance Services

In-house analytical method validation
Nitrosamine impurity analysis
Regulatory-aligned impurity profiling
Risk assessment and compliance support

We work closely with our clients to meet ICH, FDA, and EMA expectations, ensuring top-tier analytical quality and confidence in regulatory submissions.

Why Globesynth Pharma Tech?

Strong Regulatory & Analytical Expertise Aligned with ICH, FDA & EMA
Comprehensive DMF, Method Development, Validation & Transfer Support
Advanced Analytical Capabilities Including HPLC, LC–MS, MS & Prep HPLC
Robust Impurity Profiling, Nitrosamine Analysis & Risk Assessment
Audit-Ready, Regulatory-Compliant Documentation & Reporting

Scientifically Rigorous Method Validation as per ICH Q2(R1)
Accurate, Reliable & Timely Analytical Results
Customized Analytical Packages for Complex Regulatory Needs
End-to-End Analytical Support Across Drug Discovery to Commercialization
Trusted Analytical Partner for Global Pharmaceutical Companies