JRF Global’s Post

IndiGlobal Labs achieves a major milestone! 🎉 We are thrilled to announce that we have received the recognition certificate from ISP-Chile Regulatory, effective from 17th December 2024. 🌎✨ With this recognition, we are now able to conduct BA/BE studies for ISP-Chile and associated countries. This achievement highlights our unwavering commitment to global standards, quality excellence, and innovation. Stay tuned as we continue to break barriers and achieve infinite possibilities! #Recognition #Milestone #AuditSuccess #ISPChile #QualityExcellence #ComplianceAchieved #GlobalStandards #Teamwork #MilestoneAchieved #NoObservations #HealthcareInnovation #CommitmentToQuality #RegulatorySuccess #ProudMoment #GlobalCompliance #ExcellenceInAction #QualityFirst #Teamwork #ClinicalResearch #ClinicalTrials #CRO #PharmaceuticalResearch #DrugDevelopment #ClinicalData #BiomedicalResearch #ClinicalStudy #HealthcareResearch #MedicalResearch #BAstudy #BEstudy #Bioavailability #Bioequivalence #BioanalyticalServices #IndiGlobalLabs #InfinitePossibilities"

Launching an orphan drug across multiple European Union (EU) countries requires careful planning and execution. It can be incredibly challenging to decide how to balance the risks of having too much stock with not having enough. Each of the 27 member states in the EU has its own demand patters, regulatory requirements and distribution channels. In our latest article, we discuss the options available when planning your EU orphan drug stock. Learn more at: https://lnkd.in/g93ewYAG #RareDiseases #Biotechs #MarketAccess #OrphanDrugs

Launching an orphan drug across multiple European Union (EU) countries requires careful planning and execution. It can be incredibly challenging to decide how to balance the risks of having too much stock with not having enough. Each of the 27 member states in the EU has its own demand patters, regulatory requirements and distribution channels. In our latest article, we discuss the options available when planning your EU orphan drug stock. Learn more at: https://lnkd.in/g93ewYAG #RareDiseases #Biotechs #MarketAccess #OrphanDrugs

IndiGlobal Labs achieves a major milestone! 🎉 We are thrilled to announce that we have received the recognition certificate from ISP-Chile Regulatory, effective from 17th December 2024. 🌎✨ With this recognition, we are now able to conduct BA/BE studies for ISP-Chile and associated countries. This achievement highlights our unwavering commitment to global standards, quality excellence, and innovation. Stay tuned as we continue to break barriers and achieve infinite possibilities! #Recognition #Milestone #AuditSuccess #ISPChile #QualityExcellence #ComplianceAchieved #GlobalStandards #Teamwork #MilestoneAchieved #NoObservations #HealthcareInnovation #CommitmentToQuality #RegulatorySuccess #ProudMoment #GlobalCompliance #ExcellenceInAction #QualityFirst #Teamwork #ClinicalResearch #ClinicalTrials #CRO #PharmaceuticalResearch #DrugDevelopment #ClinicalData #BiomedicalResearch #ClinicalStudy #HealthcareResearch #MedicalResearch #BAstudy #BEstudy #Bioavailability #Bioequivalence #BioanalyticalServices #IndiGlobalLabs #InfinitePossibilities"

ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and European Medicines Agency earlier this year. While it brings the science of viral control up to date, practical considerations require a fuller and more detailed assessment. For this, compendia like the US Pharmacopeia and the #PhEur provide additional guidance, writes Tim Sandle, Ph.D., CBiol, FIScT in this new Bioprocess Online article. https://lnkd.in/er5Kc5ae #regulatory #biotech #ICHq5a

Considering redeeming a PRV? It can speed up your FDA review, but there’s a major catch—once it’s used, it’s gone. No second chances. Before you act, be sure you understand the risks and the stakes. Check out this latest article from Jean Chatellier, Christian Girard and myself. #PRV #RPDD #Biotech #RegulatoryAffairs #FDAApproval #PharmaInsights #HealthcareInnovation" #PRV #FDA #DrugDevelopment #PharmaInsights #Biotech #RegulatoryAffairs #PriorityReview #HealthcareInnovation" #KYBORA #Cleracsconsulting #ThePRVfundproject

Interesting new draft guidance of FDA. Realize that this also applies to in-vitro studies investigating Bioavailability or Bioequivalence and/or used to waive clinical trials. Performing these studies to GLP would be the best way forward! #Bioavailability #Bioequivalence #GLP #DMPK #Charles River

💡 Did you know? The FDA recently published a draft guidance regarding the quantity and distribution of testing samples for bioavailability and/or bioequivalence testing. According to this draft guidance, sponsors and contract research organizations (CROs) must reserve 30 single-dose or 3 multi-dose units for each test and reference product in the original container across all testing sites with at least 1 unit in the original container. The guidance applies to applicants submitting NDAs, ANDAs, supplemental applications, and CROs doing bioavailability or bioequivalence studies. 📖 Read the full text ➡️ https://lnkd.in/gRv3H65 #FDA #guidance #bioequivalence #drugdevelopment #ANDA

Navigating the complexities of international distribution. This article shares insights on the regulatory hurdles biotech companies face when entering the European market. From gaining orphan designation from the EMA to understanding national regulations and negotiating with individual EU countries, we break down the steps for success. Learn how early engagement and local expertise can make your journey to market successful. Read more here to ensure you navigate the European market with confidence. https://lnkd.in/e6BPMHHR #RareDiseases #OrphanDrugs #Biotechs