Clinical R&D services

Clinical R&D, regulatory and ethics submission services:

• Focusing on unique clinical trials that need sensitive patient population and strong regulatory & scientific support
• Qualified and experienced investigators and centers (e.g. phase 1 centres are accredited by the regulatory authorities in Hungary)
• Our clinical pharmacology specialist are ready to assist your project

Consulting and managing clinical trials with medical device,  combination product, and drug in Hungary and CEE:

• Preparation of Investigator’s Brochure, Protocol, CRF, Patient Information Sheet and Informed Consent Form
• Excellent knowledge in regulatory, ethics committee submission for medical device and combination product
• Full service including feasibility studies, monitoring, site and project management from study start-up to closure
• Investigational site training for audits

Registration services (drug, medical device):

• Preparation of preclinical and clinical dossiers for product registration
• Preparation of PIL and SmPC, readability testing
• Rx to OTC switch