Schalast | Pharma and Innovation
The pharmaceutical, biotech and MedTech sectors thrive on innovation and product development, yet operate within a highly regulated landscape. Advancements in digitalisation, Big Data and Artificial Intelligence (AI) are transforming these industries, presenting unprecedented opportunities for innovation. However, these advancements are accompanied by increasingly intricate regulations set by (EU) legislators. For biotech and pharmaceutical companies developing new drugs, aligning strategy with development and commercialisation objectives is crucial throughout the entire process. Issues related to competition law often emerge in this context. Furthermore, the pricing and advertising of pharmaceutical and medical technology products are subject to strict regulations.
We assist our clients in devising and executing such strategies, providing support throughout the entire product lifecycle. Our service includes innovative legal solutions for cutting-edge technologies facing novel issues.
We advise and represent our clients through all stages, from the inception of an idea through to the development, authorisation and distribution of a medicinal product or medical device.
WE.DO.PHARMA. | INSIGHTS
- Sustainability and social responsibility within the pharmaceutical industry
- The anticipated reforms introduced by the EU pharmaceutical package
- The influence of the proposed Green Claims Directive on the marketing of pharmaceutical products
- The effects of the EU Data Act, Artificial Intelligence (AI) and other components of the EU data strategy on the pharmaceutical sector
- The enactment of the EU Health Technology Assessment (HTA) Regulation, set to take effect from 12 January 2025