REGULATORY AFFAIRS

A full range of Regulatory Affairs activities for prescription medicines, essential similar products, OTCs, Food Supplements and others.

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.


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, biosimilars, OTCs, Food Supplements and others, ranging from an advice and consultancy service through dossier preparation and submission:

Medicines

Post-approval

  • Consultation on regulatory strategy & development of submission plan
  • New Drug Applications (CTD) through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures (MAA)
  • Orphan Drug Applications
  • Generics registration procedures

Post-approval

  • Maintenance of Marketing Authorization Applications (Variations and Renewals)
  • Adaptation & Translation of Product Information (SmPC, labelling & PIL)
  • Drug Pricing and Reimbursement Procedures

 

Medical Devices

  • Registration of medical devices to the National/European database
  • Applications for authorization of Medical Device
  • Preparation of technical dossier for CE mark
  • Regulatory activities pertaining to the import/export of medical devices

 

Cosmetics

  • Cosmetovigilance
  • Consultation and verification of compliance with applicable regulations (labeling, packaging, IFU)

 

Food Supplements / FSMPs

  • Notification to the National Competent Authority or other approving bodies (i.e. General Chemical State Laboratory)
  • Labeling and IFU development according to applicable regulations
  • Consultation on imports/exports
  • Regulatory activities pertaining to the import/export of Food Supplements

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