Regulatory Compliance Associates Inc. (RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device. Our team has navigated the front lines in Quality, Regulatory Affairs, Operations, Manufacturing and R&D. RCA provides a broad spectrum of quality, regulatory and compliance services to assist both domestic and global companies with obtaining product clearance and/or approval in the US. Whether you are implementing a Quality Management System or Remediating an Agency Action, RCA has the right resources, with the appropriate depth and breadth of knowledge, to support all your project needs. From our Senior Executives to our tactical team members, all resources have been tested in the line of fire. As your trusted partner, we can negotiate the potential minefield of regulatory compliance with insight, hindsight, and the clear advantage of our unique expertise and experience.Your trusted partner. Every strategy.Every stage. Why Choose RCA?• RCA is widely recognized within the medical device/pharma industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges • By staying abreast of changing regulations, RCA continuously evaluates FDA's current thinking and leverages thought leadership networks to advocate for our clients• We know a quality or compliance crisis can significantly impact your business. We have the experience to manage them.• We have the know-how and proven approach to navigate warning letters, consent decrees and other situations• We know how to partner with your executive, legal and communication teams• We support management to assist with the growing and changing concerns• We help navigate the storm and manage the impact to your business

Quality Systems Regulatory Affairs Manufacturing Product Development Supplier Quality Audits Training Quality Systems & Quality System Remediation Global Product Submission & Registration RA/QA Outsourcing US Agent Services US FDA Market Clearance/Approval Risk Management IND NDA and ANDA Submissions 510(k) PMA and De Novo Submissions Outsourced Quality & RA QS Implementation and/or Remediation Technical File & DHF Remediation Regulatory Action Response & Remediation M&A / Due Diligence 3rd Party GMP Expert Outsourced Quality & RA Technical File & DHF Remediation Regulatory Action Response & Remediation M&A / Due Diligence Management Consulting Management Services Consulting Business Services