We provide 

the Essential Value


We add value of your understanding of regulatory guidance on


Impurity

Extractables and Leachables

CCIT (Container closure Integrity testing)


Also, Saint-Gobain with Tubing and Bag as Single use system

SWISS BASEL, year2023 NOVEMBER, E&L SCHOOL Welcome KOREA CUSTOMER

🌐 Quality by Design Inc. - Your Trusted Partner in E&L Studies 🌐

At Quality by Design Inc., we pride ourselves on being at the forefront of the Extractables and Leachables (E&L) study landscape. Our comprehensive services cover:


🔍 Consultation on the current E&L study approach 

🔬 Critical assessment and evaluation 

📜 Extractables & Leachables study and profiling 

🧪 Identification & Toxicological evaluations 

🛡️ Risk and Safety assessments 

✅ Regulatory Registration support


Key Areas of Expertise:

  • Container closure systems like glass vials, stoppers, and related products.
  • Single-use systems and process contact materials.
  • All types of Medical Devices.

"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:

  • FDA, EMA, CHINA, KOREA, JAPAN, BRASIL, Türkiye(Turkey) and more.

Have an inquiry or need expert advice? 📩 Reach out to us at qbd@qbd.co.kr

For a more in-depth look at what we offer, visit our official website at www.qbd.co.kr

Let's navigate the complexities of E&L together! We look forward to partnering with you. 💼🌟


E&L and Pharmaceutical Regulatory Compliance AI 

*Please, click and ask chat GPTs 


Constructed by QBD


INTERTEK 자료실 Extractables Leachables 45