FDA Submissions / Applications ~ FDA Consulting Services

It takes a lot of time and resources to bring a new product to market in an FDA regulated industry, which is why it's vital that the FDA submission process goes as smoothly as possible.

Our team of FDA consultants includes industry experts, as well as former FDA employees. We can assemble, review, and analyze your data and clinical studies to make sure that your product is safe and effective. We'll ensure that your package is appropriate and acceptable for FDA submission, and that it gives you the best chance for receiving FDA approval.

We're here to assist with all of your FDA submission and application needs, including:

• 510(k), DeNovo submissions for medical devices
• Presubs for medical devices and clinical studies
• PMA (Pre Market Approval) submissions for medical devices
• IDE (Investigational Device Exemption) submissions for medical devices
• 502g submissions for medical devices
• 510k submissions for medical devices
• Classification forms for medical devices
• NDA (New Drug Application)
• ANDA (Abbreviated New Drug Application)
• NDI (New Dietary Ingredient) submissions
• GRAS (Generally Regarded as Safe) affirmations
• Structure / Function Claims for dietary supplements
• CMC (Chemistry, Manufacturing, and Controls) submissions

For more information about FDA submissions / applications, or to schedule a consultation, please contact us.

We are experienced with applications and submissions for all FDA regulated industries, including: medical devices, dietary supplements, pharmaceuticals/OTC, clinical trials, cosmetic, food & beverage, and tobacco. We also provide technical support for law firms that are assisting clients with FDA compliance.