Access to life sciences market and regulatory approval services streamlined with IP grant and protection.
Never before has entering and excelling in the China market been so important to pharmaceutical, biotechnology, medical device and life sciences companies. This is a game-changing time and for these companies to succeed they must rapidly synthesise IP issues of patent protection with a complex and frequently changing regulatory regime. The collaboration between ROUSE & CODEX brings together two market-leading businesses in China and paves the way for pharmaceutical and life sciences companies to gain seamless access to these critical areas of expertise.
COVID-19 New Environemnt
The rapid spread of COVID-19 over the last four months has focused the world’s attention on the Life Sciences community and their search for new treatments, applications and devices. The role of China as a major player has come into focus as COVID-19 has increasingly strained the pharmaceutical supply chain. In just a short time, China’s National Medical Products Administration (NMPA) has moved to fast-track the review of drugs and medical devices that might be used to prevent or treat COVID-19. NMPA’s approval and patent protection for new drugs and medical devices are likely to undergo further significant development, with speed likely to be one of the key factors in determining approval. In this new context, it will be critical to combine an understanding of NMPA’s current approval practices with effective patent prosecution strategies in order to ensure prompt market access and valuable exclusivity of IP and marketing rights.
This collaboration brings together China’s largest specialist international IP firm with the leading advisor to the life sciences industry in relation to China market entry and regulatory approval. The partnership enables clients to benefit from an unparalleled service that boasts over 300 technical specialists, including pharmacists, regulatory specialists, consultants, patent attorneys, translators and IP enforcement experts. By combining capabilities, we can now help clients create and deliver nuanced strategies based on a deep understanding of the NMPA approval procedures, as well as Patent Office and Court practices. No other offering gives life sciences clients the opportunity to maximise business and legal objectives in this critical Asian market.
The value created through an aligned ROUSE & CODEX offering is realized at three critical junctures in the following life cycle:
CODEX is a leading provider of cross-border communications based in China for medical enterprises. It is composed of full-time staff composed of advanced degrees including PhDs, with many years in medical field. With our exclusive database in life sciences, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. With our focus on life sciences, we closely work with our clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide. or Dr. Jean-Marie Blanc,