CBE30 Regulatory Strategy
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Background
A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. Their quality and engineering teams identified a solution that would eliminate the leaks by making a change to the resins in the bag. They were unclear on the submission strategy since the guidance documents were unclear. The company originally defaulted to a time-intensive Prior Approval Supplement (PAS) instead of a CBE30.
Solution
The Regulatory Compliance Associates® Inc. pharmaceutical consultants examined the corrective action, noting that the strengthening of the IV bag came from changing the ratio of the resins but not the actual resins. Because no new resins were being introduced to the pharmaceutical, RCA suggested a CBE 30 instead of the PAS.
CBE30 Result
After reviewing the RCA strategy with the FDA, the company submitted and was able to address product complaints and maintain product revenues.
About RCA’s Regulatory Services
Regulatory affairs (RA) is Regulatory Compliance Associates® (RCA) backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and/or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.
As trusted life science consultants, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. Our broad range of Medical Device Regulatory Affairs consulting services include:
New Product Approval Support
Regulatory changes are one of the most troublesome challenges facing medical device companies seeking approval of a new product. RCA® guides you throughout the research and approval process as you meet strict and changing regulations both domestically and globally. We offer a wide range of new product approval support services to help you comply with industry demands and plan mass commercialization, including:
- ISO 13485 and FDA compliance evaluations
- Global regulatory strategies like FDA 513(g) requests and product classifications
- Technical writing such as 510(k) submissions, explanation letters and clinical reviews
Post Approval Support
Our team of industry experts is here to make sure your medical device remains dependable and effective, even after it’s placed on the market. Our post-approval support solutions are designed to ensure that your product is always in compliance, with services including:
- Root cause investigation
- Corrective and preventive action support
- Complaint handling
- Recall management
Other Regulatory Services
At RCA®, we understand that no two medical device companies have the same regulatory needs. From small special projects to ongoing assistance, we offer a range of additional regulatory services and will customize a consulting solution based on your product and unique business demands. Some of our many additional services include:
- Outsourced regulatory affairs
- Regulatory affairs training programs
- Regulatory due diligence
- Regulatory gap assessment
U.S. Agent Services
RCA®. is a registered U.S. Agent, which allows us to assist international medical device companies trying to seek product approval in the U.S. As a registered agent, we can expertly handle FDA interactions on your behalf with responsibilities like:
- Assisting in FDA communication with the foreign company
- Aiding the FDA in scheduling audits
- Answering questions about the company’s medical data for submission
EU Medical Device Regulations (MDR)
If your company is looking to sell medical devices in Europe, your products will need to comply with new EU Medical Device Regulation (MDR) requirements. Our expertise allows us to assist you in EU MDR compliance through the following services:
- A comprehensive review of product portfolios and current certificate expiry dates
- Gap assessment
- Remediation and implementation of an EU MDR compliance plan
Contact RCA for Medical Device Regulatory Consulting Services
Since 2000, both small and large medical device companies around the world have trusted Regulatory Compliance Associates® Inc. as their go-to consulting service in medical device regulations. Our team of over 500 industry experts offers the hindsight and advantage necessary to give you clear guidance from beginning to end of the product submission process. No matter what your unique industry needs, count on RCA® Inc. to develop an ideal consulting solution tailored to help you comply with the industry and meet your goals.
About RCA®
Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of life science challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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