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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, 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 

의약품 인허가 관련 질문하시고 간단한 답변 받으실 수 있습니다.


E&L seminar webinarISPE KOREA 2024년도 연간교육 2024년 5월23(목) 용기 및 포장의 추출물과 침출물 평가 (E&L study)

관리자
2024-02-25
조회수 1760

ISPE KOREA 2024년도 연간교육


용기 및 포장의 추출물과 침출물 평가

(Extractables and Leachables Studies)


∘ 일 시 : 2024년 5월 23일 (목)

∘ 장 소 : 판교글로벌 R&D 센터 A동 5층 싸토리우스부설 Training Center

                  - 경기 성남시 분당구 대왕판교로 712번길 22

∘ 주 최 : ISPE KOREA

                  www.ispe.or.kr

강사소개 : 

                              (주)큐비디 대표이사 우성환 박사

                             (주)큐비디 부사장 / 인하대학교 겸임교수 강승훈 박사


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