Get PAI inspection ready
21 CFR 210/211 Compliance for Pharma Manufacturing Facilities (CMOs)
Schedule a free mini gap assessment with an ASQ-certified consultant today
What Our Clients Are Saying
Riya Interactive helped us achieve risk management file remediation on multiple class 2 heart therapy devices. They gathered all the facts and instructions beforehand, ensuring all stakeholder feedback was incorporated for our RMP, RMR, HA, and DFMEA remediations.
- Danielle, Quality Systems Manager, Boston Scientific
Riya Interactive was instrumental in developing risk files, linking FMEAs for new product development, and contributing to our SOP template. Their experience in design control, combination products, and device platform development make it easy to hit the ground running with little guidance.
- Director, Pfizer
Who We Are
Our ASQ-certified consultants are ready to bring your CMO in compliance with 21 CFR 210/211
Fortune 500, Midsize, and SMB Experience
At Riya Interactive, we know it’s important to comply with 21 CFR 210/211 as quickly as possible when bringing manufacturing to the US. As trusted experts, we've helped dozens of Fortune 500, midsized, and SMB companies do just that.
Providing ASQ-Certified Consultants for Over a Decade
We've been in business since 2013, providing ASQ-certified consultants. This ensures shorter lead times and approval on the first try, saving valuable resources and achieving PAI inspection readiness faster.
22 Years of Medical Device and Pharmaceutical Experience
As the founder of Riya Interactive, Rohini uses her 22+ years of experience in Research and Development (R&D), Quality Assurance, and Manufacturing within the Biotechnology, Pharmaceutical, and Medical Device industries to lead high-profile projects for renowned clients such as Boston Scientific, Pfizer, and Amgen.
Case Studies
Customized Solutions For Pharmaceutical & Medical Device Companies
Faster service. Flexible SOWs. ASQ-Certified Experts. ✅
Combination Product Development
Large pharmaceutical company
We provided engineering and quality support to develop a combination product compliant with 21 CFR part 4.We managed all project planning and reporting, including project execution strategies, escalation, and specific prioritizations.In the end, we successfully created all system requirements, risk management deliverables, and human factors deliverables on time.The client successfully submitted the BLA for approval.
Design History File Remediation
Large multinational medical device company
We provided program management and design quality engineers to remediate design history files per 21 CFR 820.30 and Medical Device Directive 93/42/EEC.We performed gap analyses, ensured effective risk management at external sites, and interfaced with Regulatory to provide all required submission documentation.Everything was completed on time in 10 mos.The client successfully passed their FDA and European Notified Body audits.
Get started today
Free 21 CFR 210/211 Mini Gap Assessment
Here's what to expect:
The mini gap assessment will get your team ready for:
PAI inspections
Warning letter resolution
Expedited submission documentation
Our process:
First, we'll review the QMS and interview SMEs to find gaps with 21 CFR 210/211.
Next, we'll create a report with findings.
Finally, we'll provide detailed recommendations for resolving each gap.
FAQs
Is Riya Interactive large enough to work with my CMO?
We have been in business since 2013 with a history of completing 6-figure projects with multiple resources.What companies or projects has Riya worked on?
Riya Interactive has completed 100+ projects for Medical Device and Pharmaceutical companies, ranging from the largest Fortune 500 organizations to small and mid-size companies.Where in the US does Riya Interactive work?
Riya Interactive accepts clients anywhere in the US for onsite and remote engagements.Are there any hidden costs with the free mini gap assessment?
Nope. The mini gap assessment is 100% free.Do I need to do any paperwork to schedule the free mini gap assessment?
Riya Interactive will sign an NDA. That’s it. No contracts or SOWs required.Can Riya Interactive remediate findings from the mini gap assessment?
Our team will put together a proposal to address the gaps. Once you approve, we’ll prepare an SOW, hire resources, and get to work.
111 W. Jackson Blvd. Suite 1700, Chicago, IL 60604
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