Regulatory Strategy

Each product has a certain regulatory strategy. With its expertise, HMC will provide you with an overview and detailed roadmap to help you visualize the path from research to commercialization. We will provide you with all the information to keep your progress on track and create your own financial plan.

Many of our team members are former FDA officials or former executives of leading pharmaceutical/medical device companies spanning the world. They all converge to help you have the most suitable regulatory strategy, making the path to commercialization of your product more simple.

For pharmaceuticals

We'll clarify what tests and standards you need to meet, meanwhile setting you up with a standard process to help bring your drugs to market. We also provide solutiosn for the following:

● Pre-IND and IND

● Submission before going to market

● Submitted first

● Clinical investigation.

● Global requirements to enter the market

For biological products

Regulations on probiotics are  getting increasingly complex overtime. The HMC team will advise you comprehensively to ensure that your product always passes the following tests, and other recent regulations:

● Pre-IND and IND

● Access is extended

● Submission to the market

● Send BLA

● Global requirements to enter the market

● Other prerequisites for getting your product to consumers

For medical equipment

Device type, availability of predicate devices, and technology all affect licensing and  liquidation of medical devices. HMC will help you understand how and what to submit to the licensing authority. We also advise on the following:

● Requester type (IDE, 510(k), PMA, De Novo, HUD & HDE)

● Should you apply for the FDA's Breakthrough Device Designation?

● Performance test request

● International performance standards

● Global requirements to enter the market

Your path to commercialization of your medical product will be on the right track when contacting us.