Head: Priv.-Doz. Dr. László Hetey
Lecturer for “Pharmacology and Toxicology” on the Charité - University Medicine Berlin

[ deutsch | impressum ]

We offer for You:

• Writing of Expert Reports in CTD-form: both Preclinical and Clinical Overviews / Summaries – with bibliographic research if required
• Ongoing assistance with registration procedures for national and EU registrations
• Writing of Dossiermodules for Benefit Analysis under section 35a SGB V
• Strategic consultancy in drug research and development: preclinical and clinical studies
• Processing of regulatory procedures handled by the BfArM and EMA
• Preparation of Investigational Medicinal Product Dossiers (IMPDs), CTA-procedure
• Service in Pharmacovigilance: Preparation of PSURs and Reviews of Adverse Effects
• Risk- and clinical assessment of medical devices

Since more than 15 years we have been providing pharmaceutical companies with advisory support – with competence, efficiently and inexpensively.
Dr. Hetey is thoroughly familiar with scientific and official requirements pertaining to drug development based on his long-lasting experience in the pharmacological research and in the drug registration – as former scientific co-worker of Federal Health Office and BfArM.

With his specific scientific know-how and his experience with registration authorities Dr. Hetey offers an early consultancy in drug development – until registration as quick as possible – to prevent some expensive detours or dead ends in the pharmaceutical research and development.

D-10827 Berlin, Kaiser-Wilhelm-Platz 4
Tel.: (+49 30) 787 127 60
Fax: (+49 30) 787 127 61
e-mail: hetey@hlp-pharmaconsulting.de