Regulatory affairs

The lifecycle of bringing new products to market, both pharmaceutical and medical devices, can be difficult, costly and time-consuming. Whether your new product is a drug, medical device, or a combination of the two, our staff knows the nuances of regulatory requirements and has the resources and proven expertise to meet your clinical trial approval goals.

Our regulatory experts provide a complete regulatory strategy and advise on the collection of the documentation package and the approval process for Clinical Study Protocols in Ukraine and Europe.
Our partner network includes 43 representatives from different countries with whom we provide service and advice on regulatory issues and complexities.
We have the strong knowledge and experience with local regulations, local requirements and approval procedures for EMAs and local European countries, including successful experience in the procedures and actions required to efficiently import/export investigational products, which even includes complex processes in the context of the COVID-19 pandemic.We have an in-depth and localized knowledge of the appropriate filing mechanisms for regulatory authorities (RAs) and local ethics committees (LECs).

Pharmaxi's Regulatory Affairs Services include:

  • Development of a regulatory strategy for the clinical investigation.
  • Preparation of a regulatory strategy for clinical trials of medical devices.
  • Preparation of a regulatory strategy for clinical trials of in vitro diagnostic medical devices.
  • Preparation, management, and submission of Regulatory Dossiers/Applications to Ethics Committees.
  • Preparation of Data Safety and Data Monitoring Reports.

Our main goal is to provide you with the services that best suit your needs, as well as to make our offer reasonable, time- and cost-efficient.

Contact us to discuss any questions or concerns. We kindly provide a free half-hour consultation with our expert to discuss your request.

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