case study

Strategy for Pharmaceutical Submission

A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. RCA suggested a CBE 30, which they submitted to the FDA, addressing product complaints and maintaining product revenue.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Strategy for Pharmaceutical Submission

Background

CBE30

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

RCA saved about 1 ½ years from the schedule, maintaining revenues and increasing product quality.

After reviewing the RCA strategy with the FDA, the company submitted and was able to address product complaints and maintain product revenues.

About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

pharmaceutical

 

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. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Background

CBE30

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

RCA saved about 1 ½ years from the schedule, maintaining revenues and increasing product quality.

After reviewing the RCA strategy with the FDA, the company submitted and was able to address product complaints and maintain product revenues.

About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

pharmaceutical

 

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. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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