Hudson Scientific was created by FDA and ISO regulatory experts to provide the ability for companies to bring their medical product ideas to life. We are a licensed Pharmaceutical and Medical Device Manufacturer with the State of Michigan, and are registered with the FDA.
Pharmaceutical
- New Drug Submissions.
- Repackaging Pharmaceuticals.
- Produce OTC Formulations.
- Perform Early Stability and Non-Human Clinical Studies for IND Submissions.
Medical Device
- Manufacturing Scale-up.
- Device Assembly and Kitting.
- Sterile Device Management.
- FDA Initial Import Services.
Regulatory
- New 510(k) Submittals.
- FDA Submissions.
- PMA Submissions.
- Assistance With GMP Issues.
