Accelerating the Path to Approval for Topical Generics: A Case Study in Orthogonal Advanced In Vitro Characterisation

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Bringing A Topical Generic Drug Product to Market With Confidence

Bringing a topical generic drug product to market can be technically challenging, particularly where formulation microstructure, physicochemical properties and active pharmaceutical ingredient (API) solid-state form may influence product performance.

This downloadable poster explores how orthogonal advanced in vitro characterisation (AIVC) techniques can support topical generic development, helping teams build stronger evidence of product equivalence and make more informed development decisions.

Focused on a pour-on suspension product, the case study demonstrates how a comprehensive suite of physical characterisation techniques was applied in line with FDA guidance on Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.

Download the case study to see how integrated, multi-technique analysis supported Q3 assessment across innovator and test batches.

What The Case Study Covers:

This resource provides insight into the role of Q3 characterisation in topical generic drug development, including:

The difference between Q3 Basic Analysis and Q3 Comprehensive Analysis
Why study design is critical for complex topical formulations
How orthogonal techniques can support robust product equivalence assessment
The use of high-resolution imaging, particle size distribution and phase state assessment
How pH, viscosity, rheological behaviour and polymorphic form may influence topical product performance
The value of MDRS, Raman spectroscopy and X-ray diffraction (XRD) in API and formulation characterisation

Cormica’s Expertise in Topical Generic Characterisation

With decades of experience supporting pharmaceutical and medical device clients worldwide, Cormica brings together expert scientists, advanced analytical capabilities and regulatory understanding to help clients navigate complex development challenges.

Our teams support topical generic programmes with a wide range of analytical and physical characterisation services, including method development, particle size analysis, high-resolution imaging, MDRS, Raman spectroscopy, XRD, rheology, pH assessment and broader physicochemical testing.

Working with hundreds of clients worldwide, our laboratories help development teams generate reliable, decision-ready data to support formulation understanding, Q3 characterisation and regulatory submissions.

Speak to our experts to discuss how Cormica can support your topical generic development programme.

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Authors:

Daniel Gallagher

Daniel Gallagher has 10 years’ elemental analysis experience and has spent 4 years in Cormica Bradford’s Physical Characterisation team. His expertise spans complex samples and pharmaceutical development.

Ranjith Shapur

Team Leader with 13+ years’ experience in generic pharmaceuticals and CROs, specialising in solid-state characterisation, elemental impurities, analytical methods, advanced instrumentation and regulatory compliance.

Jismon Jose

Jismon is an analytical Scientist with 10+ years of experience in solid-state material characterisation, with expertise in method development, validation, polymorphic screening, and in vitro bioequivalence studies for OINDPs.

Caroline Aiken

Caroline Aiken is Technical Director at Cormica, with more than 15 years of experience supporting the pharmaceutical industry within a CRO environment. She has also led the Physical Characterisation team at the Bradford site for eight years.

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With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.

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