Obelis partner regulatory training: takeaways from Chemron FDA Korea

Chemron FDA does business for internal and external food companies’, KFDA food-related testing, and executing approval. In addition, it offers a one-stop service that supports overseas operations using its global networks.

Since 2013, Chemron FDA Korea has been part of the Obelis International Offices (OIO) network. Some Korean customers expressed the will to sell their products in the EU, and Chemron FDA realized they had to connect with external experts to meet such needs. Thanks to the partnership with Obelis, Chemron FDA Korea now offers services for the approval of cosmetics and medical devices to companies planning to expand their business to the European market.

Recently, Sarah You, a consultant at Chemron FDA Korea, followed one of our expert’s professional trainings on EU Regulations here in Brussels, and we took the opportunity to sit with her and discuss the outcome of her training.

Why did you choose Obelis to be trained on European regulations?

Obelis has an excellent reputation in the regulatory field. Along with representative services provides its business partners with extensive training to understand EU compliance processes and regulations. As such, this was a great opportunity to build a knowledge of European regulations.

Obelis helped me learn about EU regulations and EU market entry requirements for laws that cover several products, such as medical devices, in vitro diagnostics, cosmetics, and more.

Obelis boasts experts with extensive experience in Regulatory Affairs, medical technology, lobbying, business management, marketing, and organizational development.

Davide Turchi, manager of the Regulatory Affairs department, explained how medical and non-medical devices comply with EU regulations and the CE marking process.

Francesca Santacatterina, a Publications department consultant, provided excellent cosmetics training. Her description of PIF compilation, CPNP notification, and marking were thorough.

I also had a meeting with Ajda Mihelcic, head of the Publications department, in which she gave a brief presentation on the role of Competent Authority, Notified Body and Authorised Representative (EC REP) for medical devices and IVDs.

How has this training enriched you as a professional and contributed to the success of Chemron FDA?

The intensive course has been very educational and taught me more than I even expected when I enrolled. It helped me to grow as a professional and advance in my career.

I am confident in my job. However, I can now offer superior service to my clients in Korea. Thanks to the tool and education received during the course, I upgraded the kind of service I deliver to clients interested in exporting to the European market, which is undoubtedly superior. The training and material received, became  essential tools for answering questions from Korean manufacturers.

Obelis have introduced and given us free access to their information platforms on European MDR & IVDR (MDlaw.eu) and Cosmetics Regulation (COSLaw.eu) which include news, documents, and guides.

These unique tools and a monthly newsletter help me stay updated with the newest changes.

As a partner, it felt great to receive this training. If we did not have a partnership with Obelis, acting as a consultant on EU regulations would be tough.

Based on your experience, would you recommend the course to other professionals?

I recommend this course to businesses looking to know more about EU, UK, and Swiss Regulations. I feel more confident in my own expertise and approach to asking and answering questions, and I feel completely supported by an outstanding team of regulatory professionals.

Compliance is often overlooked; however, it also determines the impact on the quality of your products and services when exported to a foreign country. It is therefore important to be trained by professionals to support our clients fully.

What is the added value to being part of Obelis International Offices (OIO)? Would you recommend being part of it?

Becoming part of the Obelis International office program gives you direct access to new resources and a new market. From a business point of view is very stimulating as while maintaining your own company identity is possible to increase capacity and resources to grow more quickly and efficiently.

On the other hand, as a professional individual, I had the chance to receive excellent training that helped me grow as an expert in my field and to stay on top in a very competitive industry. Consequently, I can help my company grow, face new challenges, and create new services for our clients. For the numerous benefits for the company and its employees, I recommend this partnership.


Are you interested in joining the Obelis International Offices Partner Community (OIOs)? Contact us now!

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Interviewer: Marketing Department at Obelis Group

Interviewee: Sarah You, Consultant at Chemron FDA Korea

5/01/2023

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