Regulatory Compliance

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Regulatory Compliance

Lambda Therapeutic Research integrates regulatory compliance into each stage of clinical development. Our procedures are structured to meet global regulatory expectations, uphold rigorous data standards, and support inspections with complete transparency. By tracking regulatory developments and applying them to study design and execution, we help sponsors progress programs with clarity and confidence.

Our Approach

Constant Monitoring

Our teams maintain an extensive regulatory-intelligence framework that tracks updates across global authorities and compliance domains. These insights are reviewed by our study start-up specialists and regulatory strategists, who translate them into actionable guidance for sponsors. This ensures that clients have reliable, current information aligned with evolving international requirements.

Innovative Digital Solutions

At Lambda, we've embraced digitalization to enhance research efficiency and streamline clinical data management processes. Since 2011, we've been leveraging advanced tools like Electronic Data Capture (EDC) technology (BizNET®) to maintain clinical study data with the highest accuracy and quality. EDC allows real-time data capture, ensuring reliability and precision in results.

Comprehensive Software Suite

Our suite of software solutions, including IMPTrack®, KnowledgeNET®, and Biolyte®, supports efficient data retrieval and streamlined access to essential study documents. These platforms help maintain data integrity and accuracy while supporting adherence to regulatory requirements. This enables reliable research outcomes and consistent compliance across studies.

Quality Management System

QEdge, Lambda’s Enterprise Quality Management System (eQMS), centralizes and strengthens quality processes across the organization. It supports compliant and efficient management of key functions, including Change Control, Deviation Management, CAPA, and related quality workflows, improving transparency, traceability, and overall operational reliability.

Efficiency and Compliance

Digital systems reduce manual steps and paperwork, lowering the likelihood of errors and improving data consistency. Electronic data capture and other automated workflows support faster data review, more reliable audit trails, and smoother compliance with global regulatory standards.

Data Integrity and Security

Digitization improves data quality by addressing common data integrity challenges through secure, controlled systems. Features such as role-based access, audit trails, and encryption safeguard all study information, ensuring confidentiality and supporting reliable, compliant clinical research operations.

Regulatory Compliance Standards

Lambda's software strictly adheres to the guidelines set forth in 21 CFR Part 11 and EU Annex 11, providing a robust and secure platform for data management and regulatory compliance.

Secure Data Archival

At the end of a clinical study, all generated data are securely archived in a NAS (Network-Attached Storage) solution and the cloud, ensuring easy and convenient retrieval of electronic information while maintaining data integrity.

Proven Regulatory Track Record

Lambda has successfully completed over 100 international regulatory inspections and audits, more than 250 sponsor audits, and 1,000+ monitoring visits. Our clinical studies, conducted using validated, regulatory-compliant electronic systems, have consistently met global regulatory expectations, reflecting our strong focus on data integrity and quality compliance.

DCGI - CDSCO - India

World Health Organization (WHO)

European Medicines Agency - European Union

CRO Inspected by MHRA - Medicines and Healthcare products Regulatory Agency - UK

Medicines and Healthcare products Regulatory Agency (MHRA) - UK

CRO Inspected by US FDA - U.S. Food and Drug Administration

U.S. Food and Drug Administration (US FDA)

CRO Inspected by ANVISA - Brazilian Health Regulatory Agency

Brazilian Health Regulatory Agency (Anvisa)

Hungary: National Institute of Pharmacy and Nutrition (OGYÉI)

Poland - Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency

National GLP Compliance Monitoring Authority (NGCMA) - Government of India

France - The National Agency for the Safety of Medicines and Health Products (ANSM)

Belgium - Federal Agency for Medicines and Health Products (FAMHP)

CRO Inspected by Thailand MoH - The Ministry of Public Health

Thailand - The Ministry of Public Health

CRO Inspected by AIFA - The Italian Medicines Agency (Agenzia italiana del farmaco)

The Italian Medicines Agency (Agenzia italiana del farmaco, AIFA)

Czech Republic: State Institute for Drug Control (SUKL)

Slovakia - State Institute for Drug Control (SIDC)

Health Canada

CRO Inspected by IGJ Netherlands - Health & Youth Care Inspectorate - the Ministry of Health, Welfare & Sport

Netherlands - Health & Youth Care Inspectorate (IGJ) - the Ministry of Health, Welfare & Sport

CRO inspected by AGES - Austrian Agency for Health and Food Safety GmbH

Austrian Agency for Health and Food Safety GmbH - AGES

Germany - The Federal Institute for Drugs & Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)

CRO Inspected by CAP - The College of American Pathologists

The College of American Pathologists (CAP)

NABL - National Accreditation Board for Testing and Calibration Laboratories. (A Constituent Board of Quality Council of India)

Spanish Agency for Medicine and Health Products (AEMPS)

Portugal - Infarmed (National Authority for Medicament and Health Products)

National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia

State Agency of Medicines of the Republic of Latvia

CRO Inspected by GCC - Gulf Cooperation Council

Gulf Cooperation Council (GCC)

Ministry of Healthcare of the Republic of Kazakhstan

CRO Inspected by HPRA - The Health Products Regulatory Authority of Ireland

The Health Products Regulatory Authority of Ireland (HPRA)

Denmark: Danish Medicines Agency (DKMA)

CRO Inspected by TGA - Therapeutic Goods Administration - Australia

Australia - Therapeutic Goods Administration (TGA)

Ministry of Health (Ukraine)

TMDA | Tanzania Medicines & Medical Devices Authority

Tanzania Medicines & Medical Devices Authority (TMDA)

swissmedic regulatory authority - inspection success

The Swiss Agency for Therapeutic Products (Swissmedic)

The logos of regulatory authorities are displayed solely for informational purposes and do not constitute endorsement or certification beyond the scope of authorized inspections and approvals.

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