Pharmaceutical Reverse Engineering Services

Reverse engineering helps decode a reference (innovator or comparator) product’s composition and critical formulation parameters. The output can range from Q1/Q2 insights (qualitative and quantitative composition) to broader physical characterization (Q3-support) and performance assessment, depending on your objective and regulatory strategy.

A key part of reverse engineering is identifying and quantifying individual excipients in finished dosage forms. Our approach combines targeted and untargeted analytical techniques with formulation know-how to provide actionable outputs—supporting decisions in development, comparability, and troubleshooting.

Clients approach us for reverse engineering services for a variety of reasons:

• Biowaiver / Bioequivalence (BE) strategies: Reverse engineering supports Q1/Q2 (qualitative/quantitative equivalence) and, where relevant, Q3 (physical equivalence) considerations to help develop generic products aligned to the reference.
• Competitive analysis: Investigate and understand the composition of competitive or reference formulations to support development strategy.
• Patent evaluation: Identify potential patent risks or support IP strategy by analysing formulation details.
• Formulation enhancement: Improve performance, stability, or manufacturability by understanding excipient roles, interactions, and contributions.
• Regulatory compliance: Identify inconsistencies or deviations in excipient composition and support remediation strategies.

Deformulation is a practical subset of reverse engineering focused on breaking down and characterizing a dosage form to understand its composition and structure. It is particularly useful when:

• the formulation is complex (multiple functional excipients, coatings, modified release systems),
• a direct “one-step” quantification is not feasible,
• you need strong evidence to support Q1/Q2 claims, or
• performance issues suggest that microstructure or excipient interactions are driving behaviour.

Deformulation work typically feeds into excipient identification/quantification, and may be complemented by physical and performance testing to connect composition with function.

Our experience in reverse engineering, drug product characterization, and formulation development makes it possible not only to quantify excipients in complex products, but also to examine formulations in detail and propose potential optimization steps.

To really understand how a formulation works, our experts can evaluate the obtained product composition and, where appropriate, our dissolution specialists can investigate release, solubility, and disintegration behaviour to connect composition to performance.

Our reverse engineering services go beyond excipient quantification—they provide context and interpretation to support decision-making in development and regulatory strategy.

Depending on the project objective and sample availability, deliverables can include:

• Excipient identification (qualitative)

• Excipient quantification (Q1/Q2) (quantitative)

• Formulation characterization summary (key functional excipients, roles, and potential critical attributes)
• Q3-supporting characterization (where applicable; e.g., physical/functional comparators)
• Performance linkage (optional): dissolution/disintegration/solubility insights supporting formulation understanding
• Recommendations for next development steps (e.g., formulation options, method refinement, risk areas)