Clinical study approval by central regulatory authorities and interaction with ethics committees can be challenging for several reasons. These reasons depend on factors such as the nature of the investigational product, available safety and efficacy data, the risk factor of the medical device, and the clinical study design. Our regulatory experts are well-versed in the submission procedures for medical devices and drugs in Poland and Ukraine.
We strive to minimize the burden on clients by managing documentation for regulatory authority (RA) submission. We start by requesting the available documentation and then prepare a checklist for any additional documents needed. In many cases, we also prepare the necessary documents to help complete the submission package.
If the customer cannot provide certain documentation, we organize consultations with Regulatory Authorities to determine which documents or explanations should be prepared. This approach helps mitigate the risk of additional questions from the RA and potential delays in the study’s approval.
Pharmaxi’s Regulatory Affairs Services:
Our main purpose is to offer you the activities that best suit your project needs while ensuring our proposal is both cost-effective 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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