Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) is a leading life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical and medical device companies. They offer expert guidance through product development, clearance, and approval processes.
Regulatory Compliance Associates (RCA), a Nelson Labs company and part of the Sotera Health group, provides comprehensive regulatory compliance consulting for the life science industry. They assist pharmaceutical and medical device companies in navigating complex regulatory landscapes, from initial product development through clearance and approval. RCA's expertise spans critical areas such as FDA submissions (including 510(k)), U.S. Agent services, CAPA management, and compliance assurance. They are dedicated to helping clients meet evolving regulatory requirements and achieve quality assurance goals. With a strong commitment to safeguarding global health, RCA partners with over 5,000 customers worldwide, including a significant portion of top medical device and pharmaceutical companies. Their team of passionate and high-performing consultants offers tailored solutions to address regulatory, compliance, and remediation challenges, ensuring clients can bring safe and effective products to market.
About
**Who they are**
Regulatory Compliance Associates (RCA) is a life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical and medical device companies. They offer guidance through product development, clearance, and approval processes.
**Expertise & scope**
* Guidance through product development, regulatory clearance, and approval processes.
* Assistance with U.S. registration and service for medical device or pharmaceutical products as a registered U.S. Agent.
* Support for regulatory, compliance, quality assurance, and remediation challenges.
* Expertise in EU Medical Device Regulation (MDR).
**Reputation / proof points**
* Headquartered in Southeastern Wisconsin with an office in Florida.
* Has assisted thousands of pharmaceutical companies.
* Has helped thousands of companies meet evolving compliance requirements.
Regulatory Compliance Associates (RCA) is a life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical and medical device companies. They offer guidance through product development, clearance, and approval processes.
**Expertise & scope**
* Guidance through product development, regulatory clearance, and approval processes.
* Assistance with U.S. registration and service for medical device or pharmaceutical products as a registered U.S. Agent.
* Support for regulatory, compliance, quality assurance, and remediation challenges.
* Expertise in EU Medical Device Regulation (MDR).
**Reputation / proof points**
* Headquartered in Southeastern Wisconsin with an office in Florida.
* Has assisted thousands of pharmaceutical companies.
* Has helped thousands of companies meet evolving compliance requirements.
Additional information
RCA positions itself as a dedicated partner for life science companies navigating complex regulatory landscapes. Their services extend from early-stage product development through post-market compliance. As a registered U.S. Agent, they facilitate essential registration and service requirements for medical devices and pharmaceuticals entering the U.S. market. The firm emphasizes its commitment to guiding clients through regulatory hurdles, ensuring adherence to quality assurance standards and addressing remediation needs.
Key Highlights
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Specializes in regulatory affairs and compliance for pharmaceutical and medical device companies.
Source
“Regulatory Compliance Associates (RCA) is a leading life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical and medical device companies.”
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Offers U.S. Agent services for medical device or pharmaceutical product registration and service.
Source
“As a registered U.S. Agent, we provide healthcare consulting assistance with U.S. registration and service for your medical device or pharmaceutical product.”
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Provides guidance through product development, clearance, and approval processes.
Source
“RCA can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.”
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Has assisted thousands of pharmaceutical companies with regulatory, compliance, and quality assurance challenges.
Source
“RCA has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges.”
Certifications & Trust Signals
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Founded as a life science consulting firm specializing in regulatory affairs and compliance.
Source
“Regulatory Compliance Associates (RCA) is a leading life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical and medical device companies.”
Buyer Snapshot
Best for
- Companies seeking U.S. Agent services for medical devices and pharmaceuticals.
- Life science firms needing regulatory affairs and compliance consulting.
- Businesses requiring support through product development and approval.
How engagement typically works
- Consultative guidance through regulatory processes.
- Direct assistance with U.S. registration and service requirements.
Typical deliverables
- Regulatory strategy and guidance.
- U.S. Agent services.
- Compliance and quality assurance support.
- Product clearance and approval assistance.
Good to know
- Best when requiring specialized expertise in pharmaceutical and medical device regulations.
HQ:
Wisconsin, US
Languages:
English
Timezones:
EST, PST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD, Food & Beverage
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Registration Support:
Yes
Inspection Support:
Yes
Product Type:
devices
Additional us_agent_fda Details
Product Types
Pharmaceuticals, Medical Devices
Registration Support
Yes
Inspection Support
Yes
Onboarding Steps
Contact RCA to learn more about the scoping process.
