What we do

At Accorto Regulatory Solutions, we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market. Our organization has perfected our processes to help companies develop bespoke, cost-effective concepts in a number of different FDA regulated areas including:

• Regulatory dossier submission strategies for new tobacco products, medical devices, drugs and other regulated consumer products including but not limited to premarket dossier preparation, publishing, and electronic submission.
• Design, planning and commissioning of compliant manufacturing facilities, cGMP SOP packages and Quality Control Systems implementation. Additional services include development, publishing and electronic submission of FDA compliant production Masterfile dossiers as well as comprehensive compliant site management services.
• As an authorized regulatory agent, we can provide regulatory support by managing responses to FDA inquiries, deficiency letters, formal meetings with Agency, on-site audit support and annual product surveillance and post market reporting requirements.

How we do it

Our key to success is speed and flexibility, while never compromising quality or our customers’ confidential information. Our promise is to put our customers’ needs at the heart of everything we do and deliver you results without excuses that are right the first time, every time. This is managed by our highly experienced leadership and technical teams, made up of industry experts with backgrounds in medical devices, diagnostics, pharmaceuticals, cosmetics, and tobacco.

Who we are