CLINICAL STUDIES

We organise all studies required for the development of generics in cooperation with our partners.


CONDUCT/ORGANISATION

In cooperation with our long-standing partners we organise

  • Bioequivalence studies
  • Pharmacokinetic studies
  • Tolerability studies

using volunteers and patients. The studies are reasonably priced and carried out reliably in EU/FDA-inspected facilities in Romania and the Republic of Moldova.


EVALUATION OF BIOEQUIVALENCE STUDIES

Even if your study has already been completed, we will be happy to advise you on all aspects of bioequivalence studies:

  • Queries from the authorities/deficiency letters
  • Strategy for presentation and argumentation in the marketing authorisation application
  • Strategy for follow-up studies
  • Consulting within the context of licensing projects

BIOEQUIVALENCE STRATEGIES

Both within the framework of new marketing authorisation procedures and for complex variations we will work with you to find the optimum strategy for the conceptual design of bioequivalence studies, handling of available bioequivalence data, evaluation  of in vitro release data, as well as study designs for special pharmaceutical dosage forms. In addition, our consulting services comprise:

  • Selection of reference products
  • Elaboration of bracketing and biowaivers for various strengths and pharmaceutical forms
  • Elaboration of BCS-based biowaivers
  • Development of strategies for scientific consultations