Century Biotech Partners Inc.

Century Biotech Partners Inc. is a management consulting company that brings innovative medical device, life science, and in-vitro diagnostic products from around the world into the U.S. healthcare market. We provide the following services.
• FDA Regulatory Consulting and Project Management. Our program management team provides thorough and comprehensive Program Management Services, navigating through the rigors of the ISO and FDA QSR regulatory environment. We can guide, develop, write, and submit the necessary documentation for the Premarket Approval (PMA) and 510K applications by demonstrating safety and effectiveness for high risk devices or “substantially equivalent” to an already marketed device. We act as your in-country FDA representative for all correspondence with the FDA and assist you in the often difficult audit process.
• Product Engineering. Our highly experienced engineering team follows a strict methodology to finely tune your product for the U.S. market, develop a product platform by incorporating product family design from strategy to implementation, and engineer products to U.S. standards and requirements.
• Market Intelligence. We provide key data, insightful forecasts and in depth analysis to strengthen your business strategy for the year ahead.
• Market Strategy and Go-To-Market Plans. We improve your competitive advantage by positioning and differentiating products towards the U.S. marketplace and provide careful planning of your market entry, product launch, and sales strategies.
• U.S. Distribution. Based on your requirements, we research, analyze, select and manage the distributors in the U.S. to ensure your innovations are brought to market and positioned for growth. We make the right choices and work to promote long term relationships between you and your distribution partners.

Company’s Keywords:

usa fda regulatory consulting, commericalization, us distribution, healthcare, consulting, medical device, singapore biotech, life science, invito diagnostic products