We Cater to Small Entity Compliance and Budgetary Requirements
Over half of our clientele consists of small to mid-sized businesses. We appreciate the opportunity to assist our clients with the expansion of their existing product line, or seizing new market opportunities. Whether this is your first experience with FDA requirements or are delving into a new regulated industry, we can provide step-by-step guidance on delivering your product to market. Our services encompass pre-design planning, through post-market surveillance and promotion.
Compliance Gurus Inc. started as a small business. As such, we are adept at working in a corporate environment that runs on tight resources, budgets and deadlines. Our team will work within your company’s economic constraints and develop an affordable project plan to accomplish your company’s goals. In addition, we will determine your company’s eligibility for FDA implemented cost-saving measures such as modified standards or user fee exemptions, based on the size or revenue, of your business.*
*The FDA defines a “small entity,” as a business with fewer than 500 employees (Drugs), or reported gross receipts or sales of no more than $100 million for the most recent tax year (Medical Devices).
Federal Food Drug and Cosmetic Act, Sections 736(d)(1)(E), 738(d)(2)(A), 738(e)(2)(A).