The first rescue medication for asthma recommended by the FDA’s pulmonary-allergy drugs advisory committee (PADAC) supports a favorable yet beneficial risk assessment using a PT027 inhaler that treats asthma in those aged 18 years and above. The FDA accepted the new drug application (NDA) for PT027 in the first half of 2022 and set a prescription drug user fee act date by 2023.
Accomplishments like this pave the way for newer innovations yet healthcare professionals and organizations (HCP/HCO) worldwide face increasing complexities in managing the intersection between a business and compliance. Life science HCPs and HCOs particularly face challenges in their attempt to benefit from rising opportunities in the market. Despite this, resilience in developing medical drugs and devices and biologics is an ever-growing factor while navigating the intricacies of regulations, documentation, and stakeholders.
The introduction of optimum compliance solutions that delivers endto- end knowledge and expertise in managing the continuous process of acquiring organizational compliance is the need of the hour for HCPs and HCOs to succeed. Through the adoption of a proactive approach and digital technology like e-compliance software applications, compliance documents and renewal of respective documents standardize this process and avoid non-compliance risks. Leveraging web-based or cloud-enabled platforms, these applications enable users to schedule multiple regulatory compliances and prerequisites for compliance management and simplified pharma product executions.
This edition of Pharma Tech Outlook Europe presents some of the most promising pharma compliance solution providers. The issue includes thought leadership articles from Alexander Bernikov, Medical Director of Clinical Development (Uro)-Oncology at Jiangsu Hengrui Pharmaceuticals, Chris Dobbs, CEng., MIET, Head of Technical Engineering at PCI Pharma Services, and Patrik Florencio, SVP and Chief Compliance & Risk Officer at Amicus Therapeutics.
This edition also showcases innovative compliance solutions from companies like CONYU, a young IT and cloud service provider and consulting firm focused on life sciences and pharma businesses.
