Regulatory services

Regulatory Strategy

Each product has a certain regulatory strategy. With its expertise, HMCwill 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. 

Regulatory Submission

Submission before commercialization is the last but not least step in determining your success. Your next business goals and plans will be guaranteed by the full preparation from HMC. Whether you're manufacturing medical devices, pharmaceuticals or biopharmaceuticals, we have a wide comprehension of the submission and preparation process. In addition to using stand-alone services, you can also combine them with an entire regulatory strategy. You'll be guaranteed accurate, timely submissions that streamline your path to approval and clearance.

 For medical equipment/Digital Health:

1. Exemption before equipment investigation

We help you understand and tailor FDA requirements. We provide services like pre-packaging your IDE, if applicable, thus ensuring you get valuable feedback from the FDA.

2. Investigative Device Exemption (IDE)

Ensure you are ready for your clinical investigation by preparing your investigation submission package.

3. Q-Send

4. 510(k) / Pre-Market Approval (PMA) / DeNovo / Humanitarian Device Exemption (HDE)

For pharmaceuticals:

1. Pre-IND

Milestone for bringing your drug to market. HMC will work with you to understand and tailor FDA requirements and prepare a pre-IND package to ensure you get valuable FDA feedback.

2. Investigational New Drug Application (IND)

We will prepare a comprehensive IND so you can begin your clinical investigation.

3. ANDA / NDA

We will help you draft a new drug application or abbreviated prescription to ensure the commercialization of the drug.

For biopharmaceuticals

1. New drug exemption / pre-investigation equipment

 We help you understand and tailor FDA requirements. Pre package your IDE, if applicable, thus enabling you to get valuable feedback from the FDA.

2. IND or IDE

We'll help you prepare the right investigative submission package, so you're ready to take on your clinical investigation

3. Biological Licensing Application (BLA)

We will compile the BLA in a neat and professional manner. In addition, we will link up with relevant parties and follow up so that your profile can be approved quickly. 

FDA 

As an industry leader, HMC will help you navigate FDA regulations and achieve compliance. We offer a wide range of capabilities such as product submission, GXP training, clinical and non-technical development, program design, product evaluation, and system monitoring. With our extensive expertise, HMC will help your product get to market quickly.

IVDR

Compared to IVD, IVDR (In vitro diagnostic regulation) is gaining more favor due to its transparent calculations and ability to maintain sustainability. With its team of scientists, HMC can advise you:

● Strategically convert from IVDD to IVDR

● Identify the list that needs to be prioritized for consideration

● Update technical documents in accordance with regulations

● Setting up a quality management system and navigation