We provide flexible, expert QA support to help you maintain compliance and scale your quality functions — without the burden of full-time hires. Our on-demand model delivers both leadership and hands-on execution, from authoring and reviewing SOPs, to conducting GMP compliance assessments, to modernizing your GMP processes to meet current regulatory expectations. Whether you need to fill a temporary QA leadership gap, support your team during audits or product launches, or maintain GMP readiness without a long-term commitment, we provide the right level of QA expertise — when and where you need it.

We help regulated organizations integrate AI into their quality systems while maintaining compliance and protecting patient safety. Our services include developing SOPs for responsible AI use in GxP environments, advising on AI system validation strategies aligned with FDA and EMA expectations, and benchmarking your QMS performance against industry best practices. Our approach ensures transparent, explainable AI processes, protects data integrity, and establishes scalable frameworks to govern future AI applications. As AI becomes a critical driver of innovation in life sciences, we guide your transformation — responsibly, strategically, and compliantly.

We help organizations build, enhance, and manage quality management system (QMS) frameworks that enable compliance, scalability, and operational excellence. Our support spans the full QMS lifecycle — from designing robust foundations to leading upgrades and platform extensions, such as Veeva Vault releases. We bring expertise as process leads, Change Managers, or Project Managers to ensure smooth and effective implementations. Our tailored approach ensures alignment with global regulatory expectations, drives efficiency through standardization and digital transformation, and supports adoption across cross-functional teams. Whether you're launching a new QMS or evolving an existing one, we deliver the leadership and insight to make your system both inspection-ready and future-ready.

We help organizations resolve compliance gaps and recover from regulatory observations or warning letters with speed and precision. Our expertise includes responding to FDA Form 483s, EMA or Health Canada deficiency letters, and third-party audit findings. We deliver root cause analysis aligned with industry best practices, CAPA planning and execution, documentation clean-up, QMS rebuilding, and interim QA leadership as needed. We also support clear communication with regulators through response letters, progress updates, and milestone reporting. Whether you're addressing findings post-inspection or proactively strengthening your systems, we help you regain regulatory confidence — quickly and sustainably.

We help organizations ensure trustworthy records and regulatory defensibility by assessing data governance practices through the lens of ALCOA+ principles. Our services include implementing audit trails, system validations, secure access controls, and compliant paper and electronic record practices. We support logbook reviews, raw data handling procedures, and storage strategies that stand up to regulatory scrutiny. This service is especially critical for FDA or EMA inspections focused on data integrity — giving you confidence that your records are complete, consistent, and inspection-ready.

We conduct comprehensive internal GMP audits designed to mirror inspections by FDA, EMA, and Health Canada, and aligned with PIC/S standards. Our audits assess QMS implementation, SOPs and records, facility and equipment controls, personnel training and hygiene, batch documentation, and data integrity risks. You’ll receive a detailed gap report outlining deficiencies, associated risk levels, and prioritized corrective actions — helping you identify and resolve compliance issues before regulators do.

We help you ensure vendor compliance and de-risk your supply chain through full lifecycle vendor management. Our services include third-party GMP audits, technical agreement support, qualification package development, and ongoing oversight using performance scorecards. We also implement remote audit strategies that align with post-COVID hybrid models. Whether managing CMOs, CDMOs, API suppliers, labs, or packaging vendors, we ensure your partners meet regulatory expectations — so your products stay compliant from start to finish.

We help organizations strengthen their quality culture and ensure lasting compliance through targeted training programs and cultural transformation initiatives. Our services include developing and delivering customized GMP and regulatory training, facilitating quality mindset workshops, and coaching teams on real-world application of compliance principles. We align training content with current regulatory expectations and your internal procedures to drive engagement, ownership, and continuous improvement. By investing in your people, we help embed quality into daily operations — making compliance a shared responsibility, not just a checkbox.