Objective: Provide flexible, expert QA support to maintain compliance and scale quality functions without the overhead of full-time staff.

We offer on-demand quality leadership and hands-on support to help you:

• Author and review Standard Operating Procedures (SOPs)

• Conduct GMP compliance assessments

• Modernize and align GMP processes with current regulatory expectations

Our fractional model allows you to:

• Fill temporary QA leadership gaps

• Support internal teams during audits or product launches

• Maintain GMP readiness without long-term commitments

Whether you're a startup building your QMS or a mature organization needing surge support, we provide the right level of QA expertise — when and where you need it.

Objective: Integrate AI responsibly into your quality systems while maintaining regulatory compliance and industry alignment.

We help regulated organizations embrace AI while safeguarding product quality and patient safety through:

• Development of SOPs for responsible AI use in GxP environments

• Consulting on AI system validation strategies aligned with FDA and EMA expectations

• Benchmarking QMS performance against AI industry best practices

Our approach ensures:

• Transparent, explainable AI processes

• Integration of AI tools without compromising data integrity

• 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.

Objective: Build, enhance, and manage QMS frameworks that enable compliance, scalability, and operational excellence.

We support the full lifecycle of QMS development and optimization, including:

• Designing and establishing robust QMS foundations

• Leading QMS upgrades and extensions (e.g., Veeva platform releases)

• Acting as process expert, Change Manager, or Project Manager throughout implementations

Our QMS services are tailored to:

• Ensure alignment with evolving global regulatory expectations

• Drive efficiency through process standardization and digital transformation

• Support seamless system adoption across cross-functional teams

Whether launching a new QMS or evolving an existing one, we provide the leadership and expertise to ensure your quality system is future-ready and inspection-ready.

Objective: Resolve compliance gaps and recover from regulatory observations or warning letters.

We specialize in helping companies respond effectively to:

• FDA Form 483 observations

• EMA or Health Canada deficiency letters

• Third-party audit findings

Our remediation services include:

• Root cause analysis (RCA) aligned with industry best practices

• CAPA planning, execution, and effectiveness checks

• Documentation clean-up and reconstruction

• QMS rebuilding or redesign

• Remediation project management and interim QA leadership

• Communication strategies for regulators (response letters, updates, milestones)

Whether you’re recovering from an inspection or preparing a proactive remediation plan, we help you regain regulatory confidence — quickly and sustainably.

Objective: Ensure trustworthy records and regulatory defensibility.

We assess data governance practices using ALCOA+ principles and help implement:

• Audit trails and system validations

• Secure access control

• Paper and electronic record compliance

• Logbook reviews and corrections

• Procedures for raw data handling and storage

This service is critical in preparation for FDA or EMA inspections focused on data integrity.

Objective: Identify and address compliance gaps before regulators do.

We perform comprehensive internal GMP audits modeled after regulatory inspections (FDA, EMA, Health Canada) and aligned with PIC/S standards. Our audits evaluate:

• QMS structure and implementation

• SOPs and records

• Facility and equipment controls

• Personnel training and hygiene

• Batch documentation

• Data integrity risks

A detailed gap report outlines deficiencies, risk levels, and prioritized corrective actions.

Objective: Prepare confidently for real inspections.

We simulate regulatory inspections under FDA (PAI, GMP surveillance), EMA (GMP compliance), or Health Canada frameworks. Services include:

• Inspection coaching and mock interviews

• Readiness assessments for documentation, site conditions, and personnel

• Custom inspection playbooks

• Risk mitigation plans for known findings

This is ideal before a market authorization application or facility expansion.

Objective: De-risk your supply chain by ensuring vendor compliance.

We support full lifecycle vendor management including:

• Third-party GMP audits

• Technical agreements and quality clauses

• Vendor qualification packages

• Ongoing oversight and scorecards

• Remote audit strategies (post-COVID hybrid models)

We help you manage CMOs, CDMOs, API suppliers, labs, and packaging vendors to ensure they meet regulatory expectations.