Regulatory Submission

Submission before commercialization is the last but not least step in determining your success. HMC supports preparation of regulatory submission materials. 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. HMC helps prepare and coordinate submissions; regulatory decisions are made by the reviewing authority.

For medical equipment/Digital Health:

1. Exemption before equipment investigation

We help you understand and tailor US Food and Drug Administration (FDA) requirements. We provide services like pre-packaging your investigational device exemption (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 support preparation of an investigational new drug (IND) application. Study initiation depends on the applicable regulatory requirements.

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 to address submission questions.