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.
Biomarker and Bioanalysis Specialists
Synexa Life Sciences is a global provider of biomarker and bioanalytical services, specialising in the development, validation and delivery of a wide range of complex and custom-designed assays. With a team of 150 across five global laboratory locations; Cape Town, London, Berlin, Turku (Finland) and Rockville (Maryland USA), we provide innovative solutions to support our customers to achieve their clinical milestones.
Our main areas of expertise include biomarker identification and development, clinical bioanalysis, soluble biomarker analysis (utilising MSD, ELISA, RIA, fluorescence and luminescence-based technologies), cell biology (including flow cytometry and ELISpot) and genomic services to support clinical trials and translational studies.
We pride ourselves on our deep scientific expertise and our ability to tackle complex problems, translating them into robust and reliable assays to support clinical trial sample analysis. We partner with our customers to contribute to the furtherment of scientific development and ultimately better management and treatment of human health.
Since, 2019, Synexa has been backed by Gilde Healthcare, a specialised healthcare investor.
Translational studies, Biomarkers, PK, PD and ADA analysis
Synexa is an immunology focused analytical CRO specialized in translational studies (target engagement assay, receptor occupancy assay, study of MoA, functionality assay), biomarker and clinical bioanalysis (PK, PD, ADA...). We are GCLP/GLP/GMP certified with labs in Europe, US and Africa. For translational studies we have access to fresh patient samples notably in Oncology, Inflammation and Auto-immunity. Synexa has numerous in-house platforms for biomarker analysis: sequencing, dPCR, Nanostring, MSD, ELISA, Delfia, AlphaLISA, Gyrolab, RIA, Flow cytometry, Multiplex IF…
Biosimilar producers: We have in-house validated developed assays for several biosimilars (Trastuzumab, Denosumab, Pertuzumab, Ustekinumab, Adalimumab, Eculizumab, Pegfilgrastim...) that we used in the past for Phase I to III,
3 areas where it could be particularly interesting to focus on:
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