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Brand Name Re-Registration with New Logo
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.
We were in jeopardy of losing confidence from our export partners; this remedy saved our reputation and prevented product backorders.
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 Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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. We 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
- Headquartered in Wisconsin (USA)
- 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.
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.
