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  • Capabilities

    Capabilities

    Our capabilities extend across the entire spectrum of clinical research services, providing end-to-end solutions for the successful development of your innovative therapies.

    Overview >

    • Strategic Product Development & Consulting
    • Early development and innovation
    • Phase II-IV Clinical Trial Management
    • Clinical Development Services (CDS) Project Management
    • Regulatory Affairs
    • Medical Writing
    • CDMO Services
    • Biostatistics & Data Management
    • Medical Affairs
    • Clinical Safety & Pharmacovigilance
    • Medical Imaging
    • eTMF
    • Quality Assurance
    • Technology
    • Labs
    Full-Service CRO Integrated Solutions That Accelerate Drug Development

    BLOG

    Full-Service CRO | End-to-End Expertise for Every Phase of Clinical Development

    PDF

    Lambda-Novum Global Corporate Presentation

    Full-Service CRO Integrated Solutions That Accelerate Drug Development

    BLOG

    Full-Service CRO | End-to-End Expertise for Every Phase of Clinical Development

    PDF

    Lambda-Novum Global Corporate Presentation

  • Therapeutic Expertise

    Therapeutic Expertise

    Empowering innovation and advancing vital therapies across diverse therapeutic areas, with extensive experience supporting over 265+ clinical trials across 15+ therapeutic domains.

    Overview >

    • Oncology & Hematology
    • Dermatology
    • Neuroscience
    • Biosimilar Development
    • Infectious Disease
    • Pulmonology
    • Cardiovascular & Metabolic disorder
    • Gastroenterology
    • Nephrology
    • Ophthalmology
    • Musculoskeletal
    • Cross-Therapeutic
    Accelerating Patient Recruitment in Ranibizumab Study for Retinopathy of Prematurity in Preterm Infants

    CASE-STUDY

    CONQUERING COMPLEX STUDIES: Accelerating Patient Recruitment in Ranibizumab Study for Retinopathy of Prematurity in Preterm Infants

    Strategic Endpoint Selection for Successful Oncology Trials - CRO

    Blog

    Strategic Endpoint Selection for Successful Oncology Clinical Trials

    Accelerating Patient Recruitment in Ranibizumab Study for Retinopathy of Prematurity in Preterm Infants

    CASE-STUDY

    CONQUERING COMPLEX STUDIES: Accelerating Patient Recruitment in Ranibizumab Study for Retinopathy of Prematurity in Preterm Infants

    Strategic Endpoint Selection for Successful Oncology Trials - CRO

    Blog

    Strategic Endpoint Selection for Successful Oncology Clinical Trials

  • Labs
  • Imaging
  • Phase-I Unit
  • Insights

    Insights

    Leveraging decades of clinical research expertise, global compliance, and therapeutic experience, we are committed to ensuring the seamless progress of your promising therapy.

    Overview >

    • Research Blogs
    • Resource Center
    • Newsletter
    • Case-Study
    • Clinical Research Update
    • Service and Capabilities
    Audit and inspection readiness - Comprehensive Approach - Lambda Therapeutic Research

    Insights

    Audit and Inspection Readiness: A Comprehensive Approach

    Case study - From Operational Strain to Compliance - PV Transformation for a Global Pharma Client

    Case-study

    From Operational Strain to Compliance – PV Transformation for Global Pharma Client

    Bioequivalence Study of Semaglutide Injection (GLP-1 analogue)

    Case-study

    Bioequivalence Study of Semaglutide Injection 1.34 mg/ml (2 mg/1.5 mL)

  • About

    Our Presence

    Leveraging decades of clinical research expertise, global compliance, and therapeutic experience, we are committed to ensuring the seamless progress of your promising therapy.

    Overview >

    • Our Approach
    • Trusted by Biotech and Pharma
    • Leadership
    • Advisory Board
    • Corporate Social Responsibility Initiatives
    • Regulatory Compliance
    • News
    • Events
    • Locations
    • Life at Lambda
    • Contact
    Bioanalytical Excellence Upheld - Unannounced US FDA inspection concludes with Zero 483s - Lambda CRO

    NEWS

    Bioanalytical Excellence Upheld – Unannounced US FDA inspection concludes with Zero 483s

    Lambda Clears 4 Back-to-Back US FDA PV Inspections in 12 Months Without 483s

    NEWS

    Lambda Successfully Completes US FDA Pharmacovigilance Inspection with Zero 483s

    Bioanalytical Excellence Upheld - Unannounced US FDA inspection concludes with Zero 483s - Lambda CRO

    News

    Bioanalytical Excellence Upheld – Unannounced US FDA inspection concludes with Zero 483s

    Lambda Clears 4 Back-to-Back US FDA PV Inspections in 12 Months Without 483s

    News

    Lambda Successfully Completes US FDA Pharmacovigilance Inspection with Zero 483s

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Lambda Therapeutic Research Logo
  • Capabilities

    Our Capabilities

    Our capabilities extend across the entire spectrum of clinical research services, providing end-to-end solutions for the successful development of your innovative therapies.

    Overview >

    • Strategic Product Development & Consulting
    • Early development and innovation
    • Phase II-IV Clinical Trial Management
    • Clinical Development Services (CDS) Project Management
    • Regulatory Affairs
    • Medical Writing
    • Technology
    • CDMO Services
    • Biostatistics & Data Management
    • Medical Affairs
    • Clinical Safety & Pharmacovigilance
    • Medical Imaging
    • eTMF
    • Quality Assurance
    • Labs
    Blog: Clinical Safety & Pharmacovigilance - Meeting MI & PV Obligations for a COVID-19 Vaccine

    BLOG

    Meeting MI & PV Obligations for a COVID-19 Vaccine

    AI in Clinical Trial: Present and Future - Lambda Therapeutic Research

    BLOG

    AI in Clinical Trial: Present and Future

    Blog: Clinical Safety & Pharmacovigilance - Meeting MI & PV Obligations for a COVID-19 Vaccine

    BLOG

    Meeting MI & PV Obligations for a COVID-19 Vaccine

    AI in Clinical Trial: Present and Future - Lambda Therapeutic Research

    BLOG

    AI in Clinical Trial: Present and Future

  • Therapeutic Expertise

    Therapeutic Expertise

    Empowering innovation and advancing vital therapies across diverse therapeutic areas, with extensive experience supporting over 280+ clinical trials across 15+ therapeutic domains.

    Overview >

    • Oncology & Hematology
    • Dermatology
    • Neuroscience
    • Biosimilar Development
    • Infectious Disease
    • Pulmonology
    • Cardiovascular & Metabolic disorder
    • Gastroenterology
    • Nephrology
    • Ophthalmology
    • Musculoskeletal
    • Cross-Therapeutic
    Overcoming Challenges in a Multicenter Oncology Clinical Trial - Lambda Therapeutic Research - Top CRO - Leading CRO

    CASE-STUDY

    Overcoming Challenges in a Multicenter Oncology Clinical Trial

    CASE-STUDY

    From Logistics to Seamless Analysis : Enhancing Medical Imaging

    Quality assurance team ensuring compliance and reliability in clinical research

    CASE-STUDY

    Overcoming Challenges in a Multicenter Oncology Clinical Trial

    CASE-STUDY

    From Logistics to Seamless Analysis : Enhancing Medical Imaging

  • Labs
  • Imaging
  • Phase-I Unit
  • Insights

    Insights

    Leveraging decades of clinical research expertise, global compliance, and therapeutic experience, we are committed to ensuring the seamless progress of your promising therapy.

    Overview >

    • Research Blogs
    • Resource Center
    • Newsletter
    • Case-Study
    • Clinical Research Update
    • Service and Capabilities

    Insights

    Audit and Inspection Readiness: A Comprehensive Approach

    Case study - From Operational Strain to Compliance - PV Transformation for a Global Pharma Client

    Case-study

    From Operational Strain to Compliance – PV Transformation for Global Pharma Client

    Case-study

    Bioequivalence Study of Semaglutide Injection 1.34 mg/ml (2 mg/1.5 mL)

  • About

    Our Presence

    Leveraging decades of clinical research expertise, global compliance, and therapeutic experience, we are committed to ensuring the seamless progress of your promising therapy.

    Overview >

    • Our Approach
    • Trusted by Biotech and Pharma
    • Leadership
    • Advisory Board
    • Corporate Social Responsibility Initiatives
    • Regulatory Compliance
    • News
    • Events
    • Locations
    • Life at Lambda
    • Contact
    Lambda Therapeutic Research Wins Global Awards: CPHI and GGB Awards 2023

    NEWS

    Lambda wins back-to-back global awards at CPHI and GGB.

    Lambda’s BA-BE Centre in India Successfully Passes GCC Inspection with Zero Observations

    NEWS

    Lambda's BA-BE Centre in India Successfully Passes GCC Inspection..

    Lambda’s BA-BE Centre in India Successfully Passes GCC Inspection with Zero Observations

    NEWS

    Lambda's BA-BE Centre in India Successfully Passes GCC Inspection..

    Lambda’s success with the prestigious ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023 in Barcelona on October 25, 2023

    NEWS

    Lambda Therapeutic Research wins back-to-back global awards

Read more about the article Bioanalytical Excellence Upheld – Unannounced US FDA inspection concludes with Zero 483s
Bioanalytical Excellence Upheld - Unannounced US FDA inspection concludes with Zero 483s - Lambda CRO

Bioanalytical Excellence Upheld – Unannounced US FDA inspection concludes with Zero 483s

  • Post author:Dipesh Chodvadia
  • Post published:July 19, 2025
  • Post category:News

NEWS

Continue ReadingBioanalytical Excellence Upheld – Unannounced US FDA inspection concludes with Zero 483s

Recent Posts

  • Bioanalytical Methods / Assay List (Lambda & Novum)
  • Study Insights: Phase-I, Bioequivalence Study of Trastuzumab SC Injection
  • Specialized Clinical Development Support for Semaglutide Programs
  • Bioanalytical Excellence Upheld – Unannounced US FDA inspection concludes with Zero 483s
  • Lambda Successfully Completes US FDA Pharmacovigilance Inspection with Zero 483s – 4th Consecutive in One Year

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Lambda Therapeutic Research Logo

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

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Capabilities

  • Strategic Product Development
  • Early Phase
  • Late Phase
  • Clinical Development Services
  • Biostatistics & Data Management
  • Medical Affairs
  • Pharmacovigilance
  • Medical Imaging
  • Regulatory Affairs
  • Medical Writing
  • Quality Assurance
  • Bioanalytical & Biosimilar Lab
  • Central Clinical Lab
  • Technology
  • CDMO Services

Therapeutic Expertise

  • Oncology & Hematology CRO
  • Dermatology CRO
  • Neurology & Psychiatry CRO
  • Biosimilar Development CRO
  • Infectious Disease & Vaccines CRO
  • Pulmonology CRO
  • Cardiovascular & Metabolic disorders
  • Gastroenterology CRO
  • Nephrology CRO
  • Ophthalmology CRO
  • Musculoskeletal CRO
  • Cell & gene therapies CRO
  • Nutraceuticals CRO
  • Pediatrics CRO
  • Women's Health CRO

Company

  • About
  • Our Approach
  • Trusted Industry Partner
  • Leadership
  • Advisory Board
  • Regulatory Compliance
  • News
  • Insights
  • Life at Lambda
  • Jobs & Careers
  • Locations
  • Contact

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