Background

A medical device manufacturer was consolidating its product portfolio, leading to a product and logo change in 15 products distributed across 60 countries. Since the company name and the manufacturing address remained unchanged, the manufacturer was unclear on the registration requirements. A brand name re-registration and logo update needed to be updated and submitted regionally. 

Solution

On a country-by country basis, Regulatory Compliance Associates^® Inc. developed the registration and customs requirements and executed the go-forward plan. In some countries, re-registration was required and RCA handled the submission.

In many countries, the bigger hurdle was ensuring the newly labeled product would pass customs requirements. RCA communicated the new brand name re-registration to the local Ministries of Health and the labeling change to distributors in each country.

Results

The manufacturer was able to change the product label and not interrupt any product sales. The brand name re-registration was approved and regulatory action has not been needed since the project ended. 

About RCA

Regulatory affairs is Regulatory Compliance Associates^® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.