Accorto Regulatory Solutions
Professional Services software - Richmond, VA, US
Accorto Regulatory Solutions Employees
Accorto Regulatory Solutions Details
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 several FDA regulated areas including: 1) 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.2) 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.3) As an authorized regulatory agent, we can provide regulatory support by managing responses to FDA inquiries, deficiency letters, formal meetings with the Agency, on-site audit support and annual product surveillance and post-market reporting requirements.
Accorto Regulatory Solutions Technologies
Email Providers
Outlook
CMS
WordPress.org
Fonts
Google Font API
Hosting
Amazon AWS