Comprehensive gathering and evaluation of all technical, clinical, and non-clinical data required for regulatory submission.
Expert structuring of modules 1-5 according to ICH guidelines, ensuring consistency, completeness, and regulatory alignment.
Professional electronic compilation with validation, quality control, and technical verification for seamless submission to health authorities.
Tailored formatting and content adjustments to meet specific requirements of target markets including FDA, EMA, and ROW jurisdictions.
Expert preparation of Investigational New Drug applications with thorough documentation and regulatory insight to support your clinical development program.
Comprehensive New Drug Application and Abbreviated NDA services ensuring complete, compliant submissions that meet FDA requirements and expedite review.
Marketing Authorization Applications prepared to European standards, addressing EMA and national authority requirements for successful market authorization.
Our lifecycle management services ensure your products maintain compliance throughout their commercial life. We provide continuous monitoring of regulatory changes, assessment of impact on your portfolio, and strategic guidance for maintaining market authorization.
We provide comprehensive review and approval of product labeling, package inserts, and promotional materials to ensure full regulatory compliance and consistency across markets.
We offer end-to-end support for initial product registrations, managing complex documentation requirements and authority interactions to secure timely approvals.
We manage license renewals and product variations strategically, ensuring continuous market presence and efficient implementation of product changes.
Thorough evaluation of existing regulatory documentation identifying deficiencies, inconsistencies, and areas requiring enhancement for compliance.
Development of comprehensive action plans with prioritized recommendations, timelines, and resource allocation for addressing identified gaps.
Expert execution of remediation activities, document updates, and quality assurance to bring materials into full regulatory compliance
Our experienced team serves as your strategic liaison with global health authorities including FDA, EMA, and MHRA. We manage all aspects of authority communication, from pre-submission meetings to post-approval commitments, ensuring clear, professional interactions that advance your regulatory objectives.
We meticulously prepare Clinical Trial Applications, including all necessary documentation and investigator brochures, ensuring efficient authority review and approval.
Our team expertly manages protocol modifications and substantial amendments, ensuring timely submission and approval to maintain study timelines.
We provide comprehensive support for safety reporting obligations, including SUSARs, DSURs, and continuous safety monitoring throughout your program.
Decades of combined experience across all major regulatory jurisdictions and therapeutic areas.
Hundreds of successful submissions and approvals for pharmaceutical and biotech clients globally.
Collaborative approach aligning regulatory strategy with business objectives for optimal outcomes.
Computerized System Validation and Instrument Qualification of HPLC, GC, UV, IR, Stability Chamber and various Other Instruments of Regulatory Industries Laboratories.Analytical instruments are precision devices used to measure, identify, and quantify chemical, physical, or biological properties of materials, ensuring accuracy, quality control, and compliance in laboratory and industrial applications.
We provide end-to-end validation of SAP, Manufacturing Execution Systems (MES), and Data Acquisition Systems (DAS) to support both manufacturing and quality operations across the enterprise. Our services ensure compliance, data integrity, and seamless integration—helping your organization achieve efficiency, reliability, and regulatory readiness.
We deliver validation and support for Laboratory Information Management Systems (LIMS) and Stability Management solutions to streamline lab workflows, ensure data integrity, and maintain regulatory compliance. Our services help manage samples, stability studies, and reporting with accuracy, efficiency, and transparency.
We provide validation and support for US and EU Serialization Systems to help you meet global regulatory requirements and protect product integrity. Our services ensure secure product tracking, compliance with DSCSA and EU FMD regulations, and end-to-end supply chain transparency.
We conduct a comprehensive assessment of your existing computer systems to identify any gaps in compliance. This assessment involves a thorough review of system documentation, processes, and controls to ensure alignment with regulatory requirements.
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We assist in identifying potential risks associated with your computer systems and their impact on data integrity, reliability, and security. Our consultants employ risk assessment techniques to prioritize risks and develop effective mitigation strategies, such as risk-based testing and validation approaches.
We provide guidance on developing and improving documentation practices, including creating validation protocols, test scripts, and standard operating procedures (SOPs). Well-documented processes and procedures are crucial for demonstrating compliance and ensuring consistent system performance.
Our experienced consultants oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing. We guide you through the testing process, ensuring adherence to protocols and best practices.
We assist in establishing robust change control and deviation management processes for your computer systems. This involves defining change control procedures, documenting change requests, assessing impacts, and implementing appropriate controls to maintain system integrity.
We make your data migration stress-free with a clear plan, thorough verification, and detailed reporting. From preparing the right migration strategy to validating data accuracy and delivering transparent reports, we ensure a smooth, secure, and reliable transition for your business.
We conduct regular reviews of computerized systems to ensure they remain compliant, validated, and fit for use. Our periodic review services cover documentation checks, system performance, data integrity, and regulatory compliance—helping you identify risks early and maintain continuous validation.
We ensure your systems run smoothly with reliable operation and proactive maintenance support. From day-to-day system monitoring to preventive maintenance and quick issue resolution, our team helps maximize uptime, extend system life, and keep your business performing at its best.
We help organizations safely retire and decommission outdated systems while ensuring data integrity, compliance, and business continuity. Our approach covers planning, data archiving, validation checks, and regulatory documentation—so you can securely transition without risks or data loss.
