Unannounced US FDA inspection concludes with Zero 483 at Lambda's Ahmedabad Facility
Unannounced US FDA inspection concludes with Zero 483 at Lambda’s Ahmedabad Facility
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Transdermal and Topical Products Early Phase BA BE Study Capabilities Lambda CRO
Transdermal and Topical Products: Early Phase BA BE Study Capabilities
Lambda conducts early phase BA/BE studies for transdermal and topical products with a focus on pharmacokinetics, adhesion performance, and skin safety. Experience spans multiple molecules and dosage forms, supported by controlled application techniques and consistent study execution.
Lambda’s Clinical Laboratory, Ahmedabad - Consistently CAP accredited since 2005
CAP Accreditation Extended till 01 March 2028, Marking Continuous Compliance Since 2005
NEWS
Accelerated Study Start for BABE Programs in India with CDSCO Prior Intimation Pathway (CT-05) Lambda CRO
Accelerated Study Start for BA/BE Programs in India with CDSCO Prior Intimation Pathway (CT-05)
The regulatory environment in 2025 was defined by consolidation, clarification, and higher expectations for execution. Across major regions, regulators focused on improving trial quality, reducing avoidable administrative burden, and enabling scientific progress while maintaining patient safety and data integrity.
FDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases
FDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases
The agency's new "Plausible Mechanism Framework" creates a first-of-its-kind regulatory pathway for genome editing and RNA-based therapies targeting small patient populations where traditional clinical trials are not feasible. The U.S.…
World Cancer Day - Patient-Centric Oncology Clinical Trials in Advancing Cancer Research - Lambda CRO
Patient-Centric Trials in Advancing Cancer Research: A Journey of Progress & Hope
On World Cancer Day, we recognize the importance of cancer research in expanding early access to investigational therapies and generating evidence that informs progress in oncology care. At Lambda Therapeutic…
EMA and FDA Publish Common Principles for AI in Drug Development - Lambda CRO
EMA and FDA Publish Common Principles for AI in Drug Development
Artificial intelligence is increasingly being applied across the medicine development lifecycle, including early research, clinical trials, manufacturing, and safety monitoring. As the use of AI expands, regulatory clarity has become…
Regulatory Developments That Shaped Clinical Trials in 2025
Regulatory Developments That Shaped Clinical Trials in 2025
The regulatory environment in 2025 was defined by consolidation, clarification, and higher expectations for execution. Across major regions, regulators focused on improving trial quality, reducing avoidable administrative burden, and enabling scientific progress while maintaining patient safety and data integrity.
From Compliance to Confidence - Lambda Pharmacovigilance Milestones 2025
From Compliance to Confidence – Lambda Pharmacovigilance Milestones 2025
Lambda Therapeutic Research provides QPPV services across the EU and UK, offering companies a reliable framework to meet regulatory expectations and maintain inspection readiness at all times.
Specialized Clinical Development Support for Semaglutide - GLP1 RA - CRO expertise
Specialized Clinical Development Support for Semaglutide Programs
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