MedPharm performs deformulation and detailed characterization of the reference product to inform Q1, Q2, and Q3 equivalence strategies.
Characterization capabilities include:
Formulations are developed to achieve equivalence with the reference product and support scale-up and regulatory submission.
Once formulations are developed, in vitro models are applied to generate the data needed to demonstrate equivalence and support regulatory submission.
MedPharm provides full regulatory support and scientific advice, either in-house or through established partners.
Regulatory acceptance criteria for topical equivalence can be challenging. Reference products may show batch-to-batch variability outside standard limits. MedPharm has experience using reference product variability data to build statistically justified acceptance criteria that are both scientifically sound and practically achievable.
