Services provided by Masha Regulatory Service

Masha Regulatory Service deals with the provision of start-up and regulatory services:

1. Study initial submission to Regulatory Authorities - preparation of the entire initial clinical trials application:
   • Preparation of an application to the President of the Office for registration of medicinal products, medical devices and biocides for the commencement of a clinical trial of a medicinal product / bioethics committee for an opinion on a clinical trial of a medicinal product.
   • Preparation, customization of the Informed Consent Form (including translation), based on local regulations
   • Essential documents from Investigators
   • Negotiating Agreements with Investigators/Institutions.
   • Organization of sworn translations of registry documents, preparation of necessary powers of attorney
   • Assistance in organizing local insurance
   • Preparing labels according to local requirements
2. During the ongoing clinical trial:
   • Adding Sites to the ongoing research - obtaining documentation from researchers, a local laboratory, negotiation of clinical trial agreements with Investigators/Institutions
   • Submitting amendments, important changes regarding study documents
   • Pharmacovigilance, distribution of safety reports - DIL / SUSAR / IND / PSRI

Masha Regulatory Service supports both commercial and non-commercial studies. Experience in submitting study in the VHP with Poland as a reference country.

Masha Regulatory Service obsługuje zarówno badania komercyjne jak i niekomercyjne, gdzie dla badań niekomercyjnych jest ustalany indywidualny, niższy cennik.