Home     The Company The History of SocraTec R&D Our Goals and Visions Our Services Quality Management System Cooperation Partners Contact / Location Clinical Investigations Clinical Pharmacology Unit Phase-I Studies Phase-II/III Studies Absorption-Site Studies Proof-of-Concept Studies Special Populations Oncology Magnetic Marker Monitoring Procedure, Basic Principle Testing Unit Study Experience Applications Biopharmaceutics Drug Substance Dosage Form BSC Classification Product Improvement Brain Trust, Expertise Consulting Service Expert Reports Network of Experts Development Concepts Infocentre Lectures/Presentations Publications/Review Articles Seminars/Conferences Links   When scientific independence and competence count The success of expert statements is fundamentally based on the quality of the scientific expertise - the capacity to evaluate question complexes with competence and authority. Here, not only does experience count, but also scientific independence - without which a convincing presentation is hardly conceivable. This also means identifying the limits of one's own expertise. Types of expert statements The question complexes for which expert opinions are required are manifold indeed. We have the competence to provide expert statements on the following: CTD - Clinical Overview CTD - Analytical Overall Summary Necessity of in-vivo studies ("biowaiver") Evaluation of study findings from clinical trials of phases I and II Interpretation of in-vitro dissolution profiles, in-vitro/in-vivo correlations (IVIVC) Proposals for formulation development (dosage forms with "added value") Biotechnology derived medicinal products ("biosimilars" vs. "biogenerics") Quality of herbal medicinal products Depending on the particular problem to be solved, in preparing statements we involve the specific capacities of distinguished external experts. Whereby our excellent contacts to international opinion leaders are indispensable.       © 2003-2012 SocraTec R&D GmbH deutsche Version Imprint