Pharmaceutical

Consultation & Services

Regulatory Guidance

Sandor Bernath, PhD, MBA

Erzsébet Deák-Renner, D Pharm
 
CMC (Chemistry, Manufacturing, and Controls)
Erzsébet Deák-Renner, D Pharm
 
Preclinical optimization
Sandor Bernath, PhD, MBA
 
Clinical trial application
 
Preparation of Investigator’s Brochure
Sandor Bernath, PhD, MBA
 
Preparation of IMPD
Sandor Bernath, PhD, MBA
Erzsébet Deák-Renner, D Pharm 
 
Clinical protocol/CRF
Katalin Szőcsik, MD
 
Clinical trial (selection, opening/initiation, closing of study sites)
 
Monitoring of Study Sites
 
Quality Management
 
Data Management
 
Biostatistics
 
GCP/GLP Auditing

 

 

 

 

 

 

 

 

 

 

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