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Global Services
Optimising "time-to-market period" is an increasingly critical requirement for pharmaceutical companies who are challenged by shrinking pipelines. Our Regulatory Affairs Department, through its extensive knowledge and experience of regulations, guidance and regulatory authority practices, can liaise on your behalf with national and international Regulatory Agencies and successfully design, build and integrate strategies that address the specific regulatory needs of your pharmaceutical organization.

We work closely together in order to achieve an efficient regulatory performance from the very beginning of the regulatory process through marketing authorization and commercialisation.

We also have the ability and knowledge to manage any kind of obligation with the Ministry of Rural Development and Food and the State General Laboratory of Greece.

We provide a full range of Regulatory Affairs activities including prescription medicines, essential similar products, OTCs, Food Supplements and others, ranging from an advice and consultancy service through dossier preparation and submission.

Our Regulatory Affairs activities include:
  • New Drug Applications (CTD) through Centralized and Mutual Recognition Procedures and National Procedures
  • Orphan Drug Applications
  • Medical Devices' Procedures
  • Essential Similar Drugs (Generics) Regulatory Procedures
  • Maintenance of Marketing Authorization Applications (Variations and Renewals)
  • Clinical Trial Applications
  • Drug Pricing and Reimbursement Procedures
CONCEPT DEVELOPMENT & STUDY DESIGN
CLINICAL TRIAL MANAGEMENT & SITE MONITORING
CLINICAL DATA MANAGEMENT
BIOSTATISTICS
MEDICAL WRITING & TRANSLATION SERVICES
CLINICAL QUALITY ASSURANCE
MEDICAL AFFAIRS & SAFETY SURVEILLANCE
REGULATORY AFFAIRS
CONSULTANCY & TRAINING SERVICES
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