HMC will aid you throughout your product development strategy from day one. The goal is to provide data systems, advice, and solutions to accelerate the device's go-to-market process, while ensuring product quality and compliance. If you do not know how to start, HMC will be the one to help you find information and present you with answers.
Product development consulting
With decades of experience,HMC is proud to be a leader in consulting and providing solutions to accelerate product development for customers in many healthcare fields such as: medical device, pharmaceutical and pharmaceutical industries, and Biopharmaceuticals. We have the resources and supports with R&D centers and other major laboratories around the world to best serve you.
Areas where HMC can assist you:
Medicine:
Know what medications you need, what tests orders should be ordered, and other questions you may have. Our regulatory strategy service will answer questions about the applicability of the subsequent to your product:
● Submission before visiting market
● Submitted first Clinical investigation
● Types of studies on safety and effectiveness
● Global requirements to enter the market
● Other relevant questions that are not included above.
Biological
For young and start-up businesses, overcoming regulatory requirements to commercialize structured products (such as biological products) can be challenging and overwhelming. We can help get your product to the global market faster by following these appropriate guidelines below:
● IND
● IDE
● Send first
● Send BLA
● Global requirements to enter the market
● Other prerequisites for getting your product into the hands of consumers
Medical devices
Did any barriers arise when entering the specified market of your medical device?
HMC can check and provide solutions in the most professional way. We have the database and world-class expertise to back you up with confidence. In HMC's strategic service, you can get support such as:
● Required submission types like 510(k), PMA, De Novo, HDE,
● Performance test request
● International performance standards
● Global requirements to enter the market
By choosing and collaborating with HMC, your products will be brought to the desired market faster. Contact us immediately for efficient results.