<식품의약품안전처 「생물학적제제 등의 품목허가·심사규정」 일부개정고시 알림 : (주)큐비디 INTERTEK 자료실

🌐 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 Guidance Law<식품의약품안전처 「생물학적제제 등의 품목허가·심사규정」 일부개정고시 알림