Regulatory Support

We assist innovative companies from the earliest stages of FDA engagement, ensuring a streamlined, step-by-step approach to regulatory compliance. With our expert guidance, companies can confidently navigate U.S. regulatory requirements.

Regulatory Support

Here are what we can do

We partner with innovative companies from the early stages of FDA engagement, ensuring a streamlined, step-by-step approach to regulatory compliance. With our expert guidance, companies can confidently navigate U.S. regulatory requirements. Our expertise ensures a seamless regulatory pathway, allowing our partners to focus on innovation with confidence.

U.S. Agent & Company Registration – We are your US partner to ensure compliance with all US regulations and registration
Document Review & Optimization – We have a strong track record of success with submissions for regulatory approval.
Applications for FDA – We have in-depth experience with NDA#, NDC#, GTIN#, and J-Code registrations.
Branding & Labeling Compliance – We develop creative brand names and strategies, logos, & labels with experience in complete documentation
eCTD Submission – Our experts prepare and manage the complete process for electronic submissions for FDA review