Regulatory affairs

Clinical study approval by central regulatory authority and interaction with ethics committees can be challenging due to a number of reasons. The reasons depend on the nature of the investigational product, available safety, and efficacy data, the risk factor of the medical device, and clinical study design. Our regulatory experts are well versed in the submission procedure for medical devices and drugs in Poland and Ukraine.

We try to minimize the burden on a client requesting documentation for RA submission. We will ask for available documentation and then we prepare a checklist for the documents that need to be added. In many cases, we prepare documents to help complete a submission package.

If the customer cannot provide certain documentation, we organize consultations with Regulatory Authorities in order to determine which documents and/or explanations should be prepared. It is an important tool to mitigate the risk of additional questions from the RA and delays to the study's approval.

Pharmaxi's Regulatory affairs Services:

  • 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 purpose is to offer you the activities that best suit your project needs, while ensuring our proposal is reasonable as well as both cost and time efficient.

Contact us with your questions or concerns. We offer a free half-hour consultation with a clinical trial expert to discuss your request.

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