Milanova&Partners has a very experienced team specialised in supporting pharmaceutical companies and CROs in their operations in Bulgaria. We advise not only on the specific regulatory and contractual matters but also on all aspects of their operations in Bulgaria including corporate, commercial, labor, tax and intellectual property.
We provide legal assistance to clients on conducting clinical trials in compliance with the provisions of the Law on Medicinal Products in Human Medicine and Ordinance No.31 on Determining the Principles for Good Clinical Practice. We also draft and negotiate contracts necessary for conducting the clinical trials, including clinical trial agreements with the PI and the Study Center, civil contract with study team members, confidentiality agreements etc..
Our lawyers advice on compliance matters related to human subjects’ protection, informed consent, privacy protections, and other regulatory matters, including data protection, data management in clinical trials and GCP compliance.
We help our client develop necessary operational policies and procedures in compliance with Bulgarian law.