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
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:
"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:
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.
Webinar: E and L Studies on Process Materials and
Container Closure Systems
Extractables and Leachables Applications
In this webinar, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, discusses extractables and leachables studies which have been performed on multiple product types and contact materials. With increasing focus by the authorities on the accurate determination of leachables in real formulations, one of the biggest challenges is to differentiate between matrix related degradation products and real leachables from the packaging or contact materials.
Typical examples are used to illustrate how, through a strategic approach, it is possible to differentiate between the two. Furthermore, these case studies will also illustrate why it is important to analyse leachables in the actual formulation and not only in extraction solutions.
WATCH NOW ->
Meet Our Expert
Dr. Tino Otte, is the Head Consulting at Intertek in Switzerland. He joined the company in 2016. Tino is specialized in extractables & leachables studies, impurity characterization and analytical method development. Tino has more than 13 years of experience in analytical chemistry, pharmaceuticals and polymer characterization.