Orgenix’ team of Regulatory experts will help your company achieve your business goals by advising on the regulatory options your company may face on the road to product approval. Our experienced team has hands-on experience in all types of submissions and requirements of US FDA, including, but not limited to:

1. Designing the strategy for and implementing all types of product approval submissions (IDE, PMA, HDE, 510(k), BLA, IND, NDA, ANDA)
   
2. Company Registrations
   
3. Providing US Agent services for non-US companies
   
4. Manufacturing Site Registration
   
5. Compliance issues
   
6. Validation issues