To help ease the regulatory burden on your shoulders, RQMIS offers support for a variety of FDA administrative activities to support your medical product's regulatory path - this includes medical devices, drugs, combination products, cosmetics and nutraceuticals.
We have experienced regulatory FDA Subject Matter Experts ready to assist you for the same cost as the big registration companies, but with infinitely more FDA regulatory knowledge. We always have your medical device, drug, nutraceutical and cosmetic' regulatory path in mind and are only a phone call away if you need anything or have questions. RQMIS provides this services for companies based in the US or in other countries. Our regulatory experts can make your company and medical devices, drugs, nutraceuticals and cosmetics products compliant with FDA Regulations.
If your business qualifies as a Small Business under the FDA guidelines for the SBD program, you could be eligible for reduced user fees for certain types of registrations/renewals with the Agency. According to the FDA, "a small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year".
Just as an example, under the 2022 User Fee schedule a small business can save over $9,500 on a 510(k) submission alone when compared to the standard fee. Check out FDA Small Business (SBD program) information for this year with our SBD FDA consultants experts.
Labeling and Product Review
FDA Compliance Monitor
Data Universal Numbering System (DUNS) Assistance
Global Unique Device Identification Database (GUDID) Submissions
Medical Device Master File (MAF) Submissions
Export Certificate to Foreign Governments (CFG)