Our validation services meet FDA, EMA, and ICH guidelines, supporting laboratories in maintaining the highest standards of quality and compliance. With decades of combined expertise, we deliver validation protocols that withstand regulatory scrutiny while optimizing operational efficiency.
​From initial risk assessment through final documentation, our team provides comprehensive validation support. We ensure your critical systems meet all regulatory requirements while minimizing production disruptions and accelerating time-to-market for your products.
Manufacturing process qualification and continued process verification
Method development, qualification, and transfer validation
Equipment cleaning procedures and residue analysis protocols
Software validation and 21 CFR Part 11 compliance
Define the commercial manufacturing process based on development knowledge and scale-up studies
Confirm the process design through Installation Qualification, Operational Qualification, and Performance Qualification
Ongoing assurance that the process remains in a state of control during routine production
Our analytical method validation services establish documented evidence that your testing methods are suitable for their intended purpose. We evaluate specificity, linearity, accuracy, precision, range, detection limits, and robustness according to ICH Q2(R1) guidelines.
From HPLC and GC methods to microbiological assays and dissolution testing, we provide comprehensive validation protocols and reports that satisfy regulatory expectations. Our expertise spans raw materials testing, in-process controls, and finished product release testing.
•Protocol design and optimization •Instrument qualification support •Reference standard qualification
•Complete parameter testing •Statistical analysis and trending •Comprehensive reporting
•Multi-site method transfer •Comparative testing protocols •Training and documentation
​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.
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.
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.
