In response to increased emphasis on generics, biosimilars and other follow-on drugs and the resurgence of domestic pharmaceutical sectors, the number of bioequivalence studies in our geographies has witnessed significant growth in recent years.

Cromos Pharma has considerable experience in the conduct of bioequivalence studies.

We offer:

  • full regulatory support
  • selection and evaluation of clinical sites
  • selection and assessment of bioanalytical laboratories
  • BE study monitoring
  • data management and biostatistics
  • preparation of final study reports
  • niche expertise in patient-based bioequivalence studies, such as in oncology, CNS, and with complex injectable drugs
  • expertise in procurement and logistics for RLD/Comparitor drugs/originator biologics

Please contact Cromos Pharma's Business Development team to get more information or to get a quote.