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.
Safety Information
Pharmaceuticals and Medical Devices Safety Information No. 345, August 1, 2017
1. Summary of Guidance for Adverse Drug Reaction Reporting by Medical and Pharmaceutical Providers
2. Important Safety Information
(1) Loxoprofen sodium hydrate (dermatologic preparation)
(2) Fluconazole, Fosfluconazole
(3) Nivolumab (genetical recombination)
3. Revision of Precautions (No. 286)
Loxoprofen sodium hydrate (dermatologic preparation) (and 16 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance
(Posted on August 1, 2017)
http://www.pmda.go.jp/english/safety/info-services/drugs/medical-safety-information/0015.html
Pharmaceuticals Revisions of PRECAUTIONS, August 3, 2017
Riociguat
Warfarin potassium
Azithromycin hydrate
Laninamivir octanoate hydrate
http://www.pmda.go.jp/english/safety/info-services/drugs/revision-of-precautions/0005.html
Risk Information which some safety measures might be taken (August 18, 2017)
Dabigatran etexilate methanesulfonate
Palivizumab (genetical recombination)
Interferon beta
http://www.pmda.go.jp/english/safety/info-services/drugs/risk-communications/0001.html