Regulatory / Advisory: Life Science and Clinical Research
2020 was the year that placed the health industry center stage. Clinical trials and research are at the forefront of innovation in medicine and Bulgaria is a hotspot for such activities - a dense network of healthcare institutions, EU legal framework and low labour cost make it increasingly more attractive for outsourcing and nearshoring in the healthcare sector.
The Clinical Trials Regulation ("CTR") is expected to:
bring significant changes to the EU approval and authorisation process in 2021;
streamline informed consent procedures and bring them up to speed with the latest data protection and privacy developments on EU level.
A major milestone to CTR's go-live date is the introduction of the single-entry EU portal for all clinical trials from across the Union which is expected to become a fact by the end of 2021. The CTR is expected to also change the regulatory landscape significantly for clinical trials in Europe. As a popular destination for the conducting of clinical trials, Bulgaria and its life science industry will be intensely affected by the new rules and preparation must start as soon as possible to ensure that no trials are caught in regulatory limbo and thus delayed or stalled. Our team of lawyers, savvy in the life science industry has advised leading international players on the interplay between EU and national regulations concerning clinical trials and is set to assist local and global players alike to make a smooth transition to the application of the new rules.
We advise companies in the pharmaceuticals / medical devices/nutraceuticals sectors and assist them in their IP protection strategies, releasing their products on the market, and structuring their marketing and advertising strategies in compliance with the applicable legislation. By protecting your non-tangible assets, we prepare our clients to capitalize on their innovations and attract fresh capital from angel and strategic investors or VC funds.
We draft licensing, distribution, and manufacturing agreements or provide the legal framework for joint R&D, training, and promotion endeavours in the pharmaceuticals industry to accommodate our client and their partners.