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Comprehensive Regulatory & Quality Compliance Solutions
At Regulatory Compliance Associates® (RCA), we specialize in providing tailored quality and regulatory solutions for companies of all sizes — from early-stage innovators to established global manufacturers. Our consultants are more than advisors; they’re problem-solvers who deliver practical, actionable strategies to meet your business goals while ensuring compliance every step of the way.
Why Work with Former FDA Consultants?
Our team is a strategic blend of former FDA Inspectors and Reviewers, seasoned industry veterans, and experienced technical specialists. With their insider knowledge, RCA helps you anticipate agency expectations, address compliance challenges before they escalate, and develop robust systems that hold up to real-world regulatory scrutiny.
Working with ex-FDA consultants means gaining a deep understanding of how the agency operates — from inspection processes to submission reviews — so you can make informed, confident decisions that reduce risk and streamline compliance.
GMP Compliance Support Tailored to Your Needs
Whether you’re establishing a new facility or evaluating an existing quality system, RCA provides expert Good Manufacturing Practice (GMP) support. Our consultants help assess current practices, implement corrective actions, and ensure your manufacturing operations are fully aligned with FDA and global regulatory requirements.
Medical Device Data Integrity and cGMP Services
Pharmaceutical cGMP Consulting
Be Inspection Ready — Before the FDA Arrives
FDA inspections are often high-stakes events. Being prepared is critical. RCA’s experts help ensure your team, documentation, and systems are inspection-ready. Our former FDA inspectors bring a unique advantage — they know what investigators look for and how to position your organization for a successful outcome.
From mock inspections and gap assessments to remediation planning and ongoing support, we help you avoid surprises and stay ahead of compliance risks.
Medical Device Compliance Training & Inspection Readiness
Pharmaceutical Compliance Training & Inspection Readiness
Full Lifecycle Support — From Product Development to Post-Market
From new product development, regulatory submissions, and risk management to post-market surveillance, remediation, and agency response, RCA can assemble the right team to deliver results — on time and within budget. Whether you’re launching a new product or responding to a warning letter, we have the expertise to support you at every phase.
Medical Device Regulatory Consulting
Pharmaceutical Regulatory Consulting
Partner with RCA for Proven Compliance Results
Ensure you’re inspection-ready, GMP-compliant, and strategically aligned with FDA expectations. Contact Regulatory Compliance Associates® today to put our team of former regulators and industry experts to work for your business.
