Home /Insights Insights NewsUnannounced US FDA inspection concludes with Zero 483 at Lambda’s Ahmedabad FacilityBlogEarly PhaseTransdermal and Topical Products: Early Phase BA BE Study CapabilitiesNewsLabsCAP Accreditation Extended till 01 March 2028, Marking Continuous Compliance Since 2005BlogEarly PhaseAccelerated Study Start for BA/BE Programs in India with CDSCO Prior Intimation Pathway (CT-05)Clinical Research UpdateFDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare DiseasesBlogLate PhasePatient-Centric Trials in Advancing Cancer Research: A Journey of Progress & HopeClinical Research UpdateEMA and FDA Publish Common Principles for AI in Drug DevelopmentBlogRegulatory Developments That Shaped Clinical Trials in 2025BlogPharmacovigilanceFrom Compliance to Confidence – Lambda Pharmacovigilance Milestones 2025BlogSpecialized Clinical Development Support for Semaglutide ProgramsNewsANVISA Accreditation renewed successfully for Lambda’s Ahmedabad and Mehsana FacilitiesBlogEarly PhaseClinical Insights from a Bioequivalence Study of Pertuzumab 420 mg Solution for InfusionBlogLabsBioanalytical Assays – Methods LibraryBlogPharmacovigilanceQualified Person for Pharmacovigilance (QPPV): Strengthening Compliance Across the EU and UKServices & CapabilitiesEnrollment Excellence in Phase-3 Semaglutide Trials – 514 Patients in Just 2 MonthsServices & CapabilitiesBioanalytical Methods / Assay List (Lambda & Novum)BlogStudy Insights: Phase-I, Bioequivalence Study of Trastuzumab SC InjectionNewsBioanalytical Excellence Upheld – Unannounced US FDA inspection concludes with Zero 483sNewsLambda Successfully Completes US FDA Pharmacovigilance Inspection with Zero 483s – 4th Consecutive in One YearClinical Research UpdateClinical Research Update – June 2025BlogClinical ResearchFull-Service CRO | End-to-End Expertise for Every Phase of Clinical DevelopmentClinical Research UpdateClinical Research Update – May 2025Case-StudyInsights: Bioequivalence Study of Semaglutide InjectionBlogLabsStudy Insights: Bioequivalence Study of Semaglutide Injection 1.34 mg/ml (2 mg/1.5 mL)BlogLate PhaseOvarian Cancer Clinical Trials – Advancing Research Through Patient-Focused ApproachesNewsLambda Ahmedabad Successfully Completes USFDA Inspection without any 483 ObservationsBiosimilarServices & CapabilitiesEnd-to-end Biosimilar Development and Clinical Trials ExpertiseLate PhaseServices & CapabilitiesAdvancing Late Phase Clinical TrialsClinical Research UpdateClinical Research Update – April 2025BlogLate PhaseStrategic Endpoint Selection for Successful Oncology Clinical TrialsBlogClinical ResearchNavigating CDSCO Regulations: Key Approval Processes and Lambda’s Regulatory SupportNewsUSFDA Approves ANDA for Protein-Bound Paclitaxel Injection: Program supported by Lambda as the key Bioanalytical PartnerBlogLate PhaseAdvancing Clinical Development in Women’s HealthBlogLabsA Highly Precise, Accurate, and Robust LC-MS/MS Method for the Quantification of Semaglutide in Human PlasmaNewsLambda Successfully Completes Multi-Site EMA Inspection for Biosimilar ProductClinical Research UpdateClinical Research Update – March 2025NewsLambda Successfully Completes Swissmedic Inspection for Pharmacovigilance ServicesClinical Research UpdateClinical Research Update – February 2025NewsSuccessful completion of the Ministry of Health inspection of the Republic of Kazakhstan (October 2024)BlogPharmacovigilanceEnsuring Drug Safety: Lambda’s Pharmacovigilance Milestones in 2024
BlogEarly PhaseAccelerated Study Start for BA/BE Programs in India with CDSCO Prior Intimation Pathway (CT-05)
Clinical Research UpdateFDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases
BlogEarly PhaseClinical Insights from a Bioequivalence Study of Pertuzumab 420 mg Solution for Infusion
BlogPharmacovigilanceQualified Person for Pharmacovigilance (QPPV): Strengthening Compliance Across the EU and UK
Services & CapabilitiesEnrollment Excellence in Phase-3 Semaglutide Trials – 514 Patients in Just 2 Months
NewsLambda Successfully Completes US FDA Pharmacovigilance Inspection with Zero 483s – 4th Consecutive in One Year
BlogClinical ResearchNavigating CDSCO Regulations: Key Approval Processes and Lambda’s Regulatory Support
NewsUSFDA Approves ANDA for Protein-Bound Paclitaxel Injection: Program supported by Lambda as the key Bioanalytical Partner
BlogLabsA Highly Precise, Accurate, and Robust LC-MS/MS Method for the Quantification of Semaglutide in Human Plasma
NewsSuccessful completion of the Ministry of Health inspection of the Republic of Kazakhstan (October 2024)
