Topical generics

Developing a bioequivalent topical drug product is a complex process. And is an undertaking that should be carried out with the utmost regard for the relationship between patients who suffer from serious illnesses and the physicians they put their trust in. The importance of selecting and characterizing the proper vehicle and bioequivalence testing can therefore not be understated. Especially when considering the industry guidance from the regulatory authorities (European Medicines Agency and the United States Federal Drug Administration). Here the ability to perform in vitro bioequivalence testing can help you to minimize your development cost and reduce the clinical program.


Our flexible organisation and profound experience in reversed engineering, deformulation and in vitro performance testing enables us to quickly generate pre-evaluation data for a scientific advice meeting. Utilizing design space and our quality management system (GMP for human and veterinary) we minimize risk and secure quality throughout the entire process. As your development partner, we will provide you all necessary support in the regulatory process, characterization of the reference listed drug (RLD), formulation development, in vitro bioequivalence studies, formulation optimization, scale-up and tech transfer.


There are several guidance documents to facilitate the development of generic products and improved patient care. Both the EMA and the FDA have published draft guidelines helping the industry with bioequivalence (BE) assessments through the use of in-vitro release testing (IVRT) and in-vitro permeation testing (IVPT) as alternatives to costly and time consuming clinical studies.

We demonstrate the bioequivalence of your product using the following approach as prescribed through this industry guidance:

  • Formulation Sameness: The test product and the RLD are qualitatively (Q1) and quantitatively (Q2) the same.
  • Similarity: The physico-chemical characterization (Q3) of the test product and the RLD are similar.
  • In Vitro Release Test (IVRT) Studies: The test product and the RLD have an equivalent rate of API release.
  • In Vitro Permeation Test (IVPT) Studies: The rate and extent of drug permeation through excised human skin from the test product and the RLD are comparable.


Zelmic organisation can facilitate an accelerating development program covering the full service e.g. supporting Q1/Q2/Q3 Bioequivalence Waiver and Sameness Testing, analytical work, formulation development, pivotal studies and statistical analyses, regulatory service, and tech transfer to CMO.



Contact us to inquire about how we can help you to get your generic drug product to the market quickly and safely.

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