Resources

Explore our extensive resources to uncover more about RCA's expertise in life sciences consulting.

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Podcasts

Cybersecurity Challenges in Connected Medical Devices

In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI Group to unpack the evolving...
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Case Studies

Integrating Device Design into a Biosimilar Program

Background An established pharmaceutical company with a strong background in biologics and biosimilars was preparing to enter Phase 3 clinical trials with a biosimilar product. While their drug development and...
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Webinars

Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change

A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch for an in-depth exploration of PDA/ANSI Standard 06-2025: Assessment of Quality Culture, a...
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Blogs

A Regulatory Roadmap for Combination Product Submissions

Combination product submissions require a tailored regulatory strategy that blends device, drug, and biologic requirements. The complexity increases when multiple FDA centers could be involved. The journey begins with identifying...
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Blogs

Do You Actually Have a Combination Product? Here’s How to Know

Many companies don’t realize they have a combination product until it’s too late. With increased regulatory scrutiny from the FDA, properly identifying your product type is not just important—it’s essential...
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Blogs

Design Controls for Combination Products: The Most Common Compliance Gap

Why Design Controls Matter for Combination Products Design controls represent one of the most significant regulatory challenges for companies entering the combination product market, especially those with a pharmaceutical or...
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