Reverse Engineering & Comparative Studies

GMP-compliant analytical comparison of pharmaceutical products to support development and lifecycle decisions

Understanding the composition and critical quality attributes (CQAs) of pharmaceutical products is essential to support development, optimize formulations, and manage lifecycle changes. Comparative analytical studies provide key insights into differences between products, helping to guide technical and strategic decisions.

Kymos Group offers GMP-compliant reverse engineering and comparative studies using an integrated analytical approach. By combining particle characterization, solid-state analysis, and compositional assessment, we support the evaluation of reference and test products across a wide range of pharmaceutical formulations.

Services

Our catalog of services include:

Product Understanding & Compositional Analysis

Analytical characterization of APIs and drug products to help determine composition and critical quality attributes (CQAs)

Comparative Analysis

Comparative studies between test and reference products based on particle, solid-state, and compositional attributes
Evaluation of similarities and differences to support development programs and product benchmarking

Investigation of Formulation & Process Differences

Assessment of changes related to formulation, manufacturing processes, or raw materials
Integration of microscopy, spectroscopy, and thermal analysis techniques

Supplier & Material Comparison

Evaluation of materials or products from different suppliers based on physicochemical and particle attributes
Assessment of consistency, quality, and impact on final product performance

Where can we help

Key Applications

Reverse engineering and comparative studies provide critical insight to support development programs and lifecycle management, particularly when understanding differences between products is essential.

Comparative studies between test and reference products
Evaluation of supplier or raw material changes
Troubleshooting formulation and process variability
Support for product development and optimization
Lifecycle management and post-approval changes

OUR EXPERIENCE

We can help you with:

Our experience covers a wide range of pharmaceutical products and materials, including:

APIs (small molecules)
Drug products (solid and liquid formulations)
Excipients and raw materials
Complex formulations and advanced drug delivery systems

Why Choose KYMOS?

GMP Expertise:
- GMP-certified laboratories supporting reverse engineering and comparative studies across development and commercial stages.
Integrated Analytical Approach;
- Combination of particle, solid-state, and compositional analysis to provide a comprehensive understanding of pharmaceutical products.
Decision-Oriented Support:
- Generation of analytical data to support technical evaluation, development strategies, and lifecycle decisions.
Proven Track Record
- Extensive experience supporting pharmaceutical companies in development, troubleshooting, and product optimization.

Services

All Solid-State Characterization Services

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Particle Characterization & Testing

GMP-compliant characterization of particle size, morphology, and solid-state properties to support development and quality control.

Foreign Particle Identification

GMP-compliant identification and characterization of visible and subvisible particles to support contamination investigations and root cause analysis.