Regulatory Compliance Associates® Inc. (RCA) is Your Go-To Source for Complex Regulatory Challenges
We’re widely recognized within the life science industry and global regulatory agencies for our ability to help companies successfully resolve complex regulatory challenges. By mining regulatory intelligence, we continuously evaluate the global regulatory audience and leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.
Medical Device
Our breadth of expertise in the Medical Device industry is globally renowned and in demand. Our services include regulatory affairs, assessments and audits, agency response, preparation and remediation, and strategic consulting on new product development, lifecycles, and staffing support.
Recent News
FDA Publishes Updated Biologics Guidance
The US Food and Drug Administration (FDA) recently issued final guidance (June 2021) for Biologics industry executives to help define modifications to existing products and update submission procedures. The...Read More
FDA Publishes Updated Security Guidance
The U.S. Food and Drug Administration (FDA) recently published (June 2021) four new guidances to help accelerate supply chain security and new product tracing requirements in the pharmaceutical industry. While...Read More
How Brexit is Impacting Medical Device Companies
Medical Device Regulations Changes coming with Brexit. Listen to this highlight from RCA Radio where Seyed Khorashahi breaks down the UK’s Medical Device Regulations by choosing not to join the EU...Read More
FDA Guidance on Product Lifecycle Management
By: Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates Inc. The USA Food and Drug Administration (FDA) recently provided updated regulatory guidance for Product Lifecycle Management in the pharmaceutical...Read More
Understanding the First Steps to Upgrading a Facility
Deciding whether to build a new facility (greenfield) or update an existing facility (brownfield) it is important to understand the regulations governing facilities and inspection readiness. The Code of Federal...Read More
FDA Expands Virtual Audit Guidance
By: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. The US Food and Drug Administration (FDA) has recently expanded on its clarification of remote video manufacturing audits and how...Read More
News
Vice News Interview: Coronavirus Is Revealing Gaping Holes in America’s Drug Supply Chain...
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Regulatory Compliance Associates® Inc. Welcomes Steven Lynn as Executive Vice President of Pharmaceuticals...
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Susan Schniepp Makes Impression With Talk About Quality Culture in Berlin...
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