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​Clinical Trials Services

​LEF ensures phase I clinical trial for formulation bioequivalence testing, particularly BA/BE  assessment, in accordance with GCP compliance, respecting all phases of developed product and meeting your product development timetable to reduce time-to-market.

All support is given to assure your expectations and regulatory demands, until the final approval by authorities (National and ​European authorities).

All regulatory issues, like study submission and notification duties, are handled by us.

Services
  • Clinical trials and Bioavailability and Bioequivalence studies (200 beds available);
  • In vitro-In vivo Correlations (IVIVC);
  • Consultancy;
  • Study Design Development;
  • CRF development;
  • Clinical Trial Monitoring;
  • Pharmacocinectic Analysis;
  • Statistical Analysis – SAS Code Programming;
  • Protocol and Report writing.

​Bioanalytical services

LEF has experience in the development and validation of pharmaceutical quantification methods and/or of its metabolites in several types of biological matrices like plasma, serum, urine and biological tissues.

Pharmaceutical quantification in biological matrices is performed in accordance with OECD-GLP requirements. Our available analytical techniques include LC-MS/MS, GC-MS and HPLC-UV.

Several methods were developed and validated in different biological matrices, with the purpose of analytes quantification in human biological samples, as well as in animal tissue residues.