Regulatory Affairs

Our Regulatory department provide support across all phases of your clinical development project. From the start up activities of your clinical trial to the product registration and application for Marketing Authorization. With over 20 years of experience in the field, our regulatory experts have the know-how to interact effectively with the local Competent Authorities and Ethics Committees and successfully accomplish project's goals.

Clinical Trials
As the regulatory environment is driven to change, the challenges the clinical trial industry is experiencing during the initiation of a study are continuously increasing. Our Study Start Up specialists are always up to date with the national and international legislation developments and able to ensure quality compliance in all local regulatory activities. What makes us so competitive, however, is the ability to reduce the time from cost proposal acceptance to study activation and enrolment start.

iCOS, our new clinical service, was the result of the implementation of the ministerial decision G5A/59676/21.11.2016 in order to support foreign CROs and foreign sponsors in the performance of their clinical research and regulatory projects. More specifically, iCOS may represent either your CRO or you, as a sponsor, when performing studies in Greece, offering you the fulfilment of all clinical trial sponsorship obligations and relieving you from the responsibility of establishing a legal entity in Greece.

Product Marketing Authorization & Registration Process
A perfectly well-planned regulatory strategy is the key for granting marketing authorization of your product. Our regulatory expertise along with our continuous legislation-updates tracking is what gives us the confidence to guarantee your success. The regulatory team may provide reliable consultation and support to every kind of regulatory project.

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:

  • Consultation on Regulatory Strategy & development of submission plan.
  • Marketing Authorization Dossier Compilation & Submission through:
    •  National Procedures (MAA)
    • Mutual Recognition Procedures (MRP)
    • Decentralized Procedures (DCP)
    • Centralized Procedure (CP)

 

How can we help you?