Scientific advances and technological innovations go hand in hand with the increased regulatory scrutiny on businesses operating in the Life Sciences industry. Our team has assisted clients on various topics, including marketing authorization, medical devices, biosimilars, and clinical trials.
What we do
We advised, working alongside an international law firm, a multinational pharmaceutical and bio-tech company on the national regulation in the field of biosimilars and on the current state of the implementation of the relevant EU legislation into the national laws.
We acted for the investors in a clinical trials and tissue procurement company. In the context of the acquisition our advice included full legal due diligence with industry specific legal analysis relating to medical research and tissue procurement.
We advised, along with an international law firm, a pharmaceutical company in relation to the transfer a clinical trial agreement under Bulgarian law where the transfer included the IND and the role of sponsor to a third party company for the remaining cycle of the clinical trial.
Advised and successfully defended a multinational pharmaceutical company in an alleged price fixing and bid rigging investigation proceedings.