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Good Clinical Practice (GCP)

  • Investigator Site Audits: Our experienced auditors conduct routine, directed, and for-cause audits of investigator sites. Through meticulous assessments, we identify areas for improvement and verify the adherence of site practices to GCP standards.
  • Study/System Audits: We offer comprehensive audits of Phase I units/studies, Bioavailability (BA)/Bioequivalence (BE) studies, CROs, and sponsors. Our audits evaluate the compliance and performance of these entities, ensuring the reliability and accuracy of study data.
  • Mock Inspections: In preparation for regulatory inspections, we conduct mock inspections of sites, CROs, and sponsors. Our tailored programs include inspection readiness activities, equipping organizations with the knowledge and tools needed to excel during actual inspections.

Good Pharmacovigilance Practices (GVP)

  • PV Process Audits: Our experienced team conducts rigorous audits of the pharmacovigilance processes of sponsor country organizations. These audits assess the effectiveness and compliance of pharmacovigilance activities, helping organizations identify areas for improvement.
  • Quality Management System: We assist companies in developing and implementing robust Quality Management Systems (QMS) for pharmacovigilance. Our tailored solutions ensure adherence to regulatory requirements and best practices, enabling effective management of safety data.
  • Drug Safety Unit: We provide comprehensive support in managing the entire drug safety lifecycle, from case receipt to submissions, safety surveillance, and aggregate reporting. Our services ensure timely and accurate reporting of adverse events, facilitating compliance with regulatory obligations.

Good Laboratory Practices (GLP)

  • Facility Audits: Our experienced auditors conduct thorough assessments of laboratory facilities to evaluate compliance with GLP regulations. We assess the adequacy of infrastructure, equipment, and processes to ensure accurate and reliable testing results.
  • Study Audits: We perform in-process and retrospective audits of laboratory studies to ensure adherence to GLP principles. Our audits encompass the entire study lifecycle, from protocol design to data collection, analysis, and reporting. We identify areas for improvement and provide recommendations to enhance study quality and compliance.
  • CRO Qualification Audits: We assist organizations in selecting and qualifying Contract Research Organizations (CROs) for laboratory studies. Our comprehensive audits evaluate the CRO’s capabilities, infrastructure, quality systems, and adherence to GLP regulations. We help clients make informed decisions and establish effective partnerships with reliable CROs.

Good Manufacturing audits

  • Quality Management Systems: We assist organizations in developing and implementing robust Quality Management Systems (QMS) tailored to their specific manufacturing processes. Our solutions help establish effective quality control measures, documentation practices, and change control procedures, ensuring the highest standards of product quality and regulatory compliance.
  • Data Integrity Audits: We perform comprehensive audits to assess data integrity practices within manufacturing organizations. Our audits evaluate data management processes, electronic systems, data security, and record-keeping practices to ensure the accuracy, completeness, and reliability of critical manufacturing data.
  • Quality Control Activities Assessment: We assess quality control activities within manufacturing operations, including testing methods, equipment qualification, and laboratory practices. Our evaluations help identify areas for improvement, enhance product quality, and ensure compliance with regulatory standards.

Vendor Audits

  • Medical Information Vendors: We assess medical information vendors to ensure accurate and reliable handling of medical inquiries, adherence to standard operating procedures, and compliance with regulatory guidelines. Our audits help identify areas for improvement and ensure the delivery of high-quality medical information services.
  • Call Centres: We conduct audits of call centres to assess their customer service practices, adherence to scripts and protocols, data security measures, and compliance with regulatory requirements. Our evaluations help ensure effective communication and proper handling of customer inquiries.
  • Market Research Vendors: We evaluate market research vendors to ensure compliance with data privacy regulations, ethical research practices, and accurate data collection and analysis. Our audits help organizations obtain reliable market insights while maintaining compliance with industry standards.


  • Inspection Readiness: We assist organizations in preparing for regulatory inspections by conducting thorough assessments, identifying potential gaps, and developing robust strategies to ensure readiness. Our consultants provide guidance on documentation preparation, staff training, and mock inspections to help organizations demonstrate compliance and achieve successful inspections.
  • Corrective and Preventive Action (CAPA) Management: We help organizations establish effective CAPA management systems to address identified issues, prevent recurrence, and drive continuous improvement. Our consultants work closely with clients to develop streamlined processes, implement CAPA tracking systems, and provide training on CAPA best practices.
  • Quality Management System (QMS) Development: We support organizations in designing and implementing robust QMS frameworks aligned with industry standards and regulatory requirements. Our consultants assess existing systems, develop tailored QMS documentation, and provide guidance on process optimization, risk management, and performance metrics.


Computer / Electronic System Audit

  • System Development Life Cycle (SDLC): We assess the entire life cycle of computer systems, from initial development to retirement, to ensure adherence to best practices and regulatory requirements. Our auditors evaluate system design, development, testing, implementation, and maintenance processes to identify potential risks and gaps.
  • Computer System Validation (CSV): We offer in-depth validation services to ensure that computer systems meet regulatory requirements and perform as intended. Our auditors review validation documentation, protocols, and reports, assessing the effectiveness and compliance of the validation activities conducted throughout the system’s life cycle.
  • Business Continuity: We assess the strategies and measures implemented to maintain uninterrupted business operations in the event of unforeseen disruptions. Our auditors evaluate business continuity plans, backup and recovery processes, and system redundancy to ensure organizations can effectively mitigate risks and minimize downtime.


Good Pharmacoepidemiology Practices (GPP)

  • Study Audits: We conduct thorough audits of pharmacoepidemiology studies to assess compliance with protocols, regulatory requirements, and industry best practices. Our experienced auditors evaluate study design, data collection methods, analysis techniques, and overall study conduct to ensure robust and reliable results.
  • Protocol Review: Our experts meticulously review study protocols to ensure they are scientifically sound, ethically compliant, and aligned with regulatory guidelines. We assess the study objectives, methodologies, sample size determination, data collection tools, and statistical analysis plans to ensure the validity and integrity of the research.
  • Qualification of Personnel & Role and Responsibilities: We assist organizations in identifying and qualifying personnel involved in pharmacoepidemiology studies. Our team evaluates the qualifications, training, and experience of key study personnel to ensure their competence and adherence to relevant regulations and guidelines.


  • Basic and Advanced GCP Training: Our GCP training courses cater to individuals at all levels of experience. We provide comprehensive training on the fundamental principles and regulations governing Good Clinical Practice, ensuring participants have a strong foundation in ethical conduct, data integrity, and patient safety.
  • Mastering Audit Skills: Our specialized training equips professionals with the necessary skills and techniques to excel in conducting audits. Through interactive sessions and practical exercises, participants learn how to plan and execute effective audits, assess compliance, and communicate findings in a concise and impactful manner.
  • Managing Customer Audit and Hosting Regulatory Inspection: We offer training programs that prepare organizations to effectively manage customer audits and regulatory inspections. Participants gain insights into the audit and inspection processes, learn how to establish robust inspection readiness strategies, and develop the necessary skills to navigate these critical events seamlessly.


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