• Bioequivalence Trials, Phase I Trials
• Bioanalytics, Pharmacokinetics, Metabolism
GEA Pharmaceutical A/S has many years of experience in the planning, conducting, evaluating and reporting of bioequivalence
trials. A deep insight into the pharmaceutical characterization, in vivo – in vitro correlations sometimes, helps to
reduce the risk of failed trials.
Our bioanalytical group is performing method development and method validation according to GLP quality standards. Most
of our analytical tasks are solved by use of HPLC-MS/MS. Other analytical equipment is available as well if needed.
Our biostatistical methods and procedures are fulfilling the requirements of the EMEA, FDA and other non-EU Authorities.
Healthy volunteers units are usually subcontracted but in any case audited and certified by various Regulatory
Authorities and were used in the past for numbers of successfully completed Marketing Authorizations.
We have over 15 years of experience in project managing clinical parts of bioequivalence studies in Scandinavia,
EU, Canada, South Africa, and Latin America.
CLINICAL DEVELOPMENT
