Audit Services

Audits: The Art of identifying opportunities, addressing challenges and mitigating risk

Audits are a practical and objective exercise to verify and validate the efficacy of processes in an organization’s QMS (quality management system). Many perceive audits to be intrusive and costly but they represent a great tool to gain insight into your quality department.

For over 40 years, small, medium, and multi-national organizations have hired MCS experts to conduct comprehensive good manufacturing practices audits (cGMP audits) and to provide quality control services required for regulated products and activities. Our teams have improved existing pharmaceutical quality management systems and helped to implement quality assurance initiatives. Our experts have a long history of providing economical, efficient, and pragmatic remediation guidance as one of the trusted quality control services and GMP Audit service providers throughout the world.

1. Regulatory Scrutiny is Increasing

Health Canada, the U.S. FDA, EMA, and other agencies are tightening their enforcement actions, demanding greater transparency and accountability from both manufacturers and their suppliers. Third-party audits help ensure you meet expectations before the regulators arrive.

2. Global Supply Chains Multiply Risk

With APIs, excipients, packaging, and finished products often sourced from multiple geographies, the risk of quality lapses, contamination, or data integrity breaches grows exponentially. Independent cGMP audits of contract manufacturers (CMOs), vendors, and distributors help mitigate these risks.

3. Internal Audits Are Not Always Objective

In-house teams can overlook deficiencies due to familiarity bias or resource limitations. A third-party perspective brings fresh insight, objective benchmarking, and deeper regulatory expertise.

4. Partners Demand Proof

Whether you’re entering a co-marketing deal or distributing internationally, partners expect documented proof of GMP compliance. A third-party audit by a trusted firm like MCS builds that trust.

5. Post-Inspection or Warning Letter? Don’t Go It Alone

Remediation following a Form 483 or Health Canada compliance rating downgrade requires expert intervention. Our third-party audits support CAPA development, root cause analysis, and regulatory response planning.

MCS Associates is a trusted auditing partner for life sciences, food, and wellness brands across North America and globally. With deep technical expertise and up-to-date knowledge of GMP auditing standards, we provide comprehensive, risk-based assessments that help clients demonstrate compliance, qualify vendors, and prepare for regulatory inspections with confidence.

We specialize in GMP audits for:

• Pharmaceuticals (Health Canada, FDA, EMA)
• Natural Health Products (NHPs)
• Dietary Supplements (21 CFR Part 111)
• Cosmetics (Health Canada & FDA Guidelines)
• Medical Devices (MDSAP, ISO 13485)
• Foods (SFCR, FDA FSMA, HACCP, GFSI Schemes)

Whether you’re preparing for a Health Canada inspection or evaluating a global supplier, MCS delivers audits that are strategic, actionable, and aligned with current international standards.

Our audit protocols are built on globally harmonized quality frameworks, including but not limited to:

• ICH Q7, Q9, Q10 Quality Guidelines
• WHO GMP and PIC/S GMP frameworks

We continuously monitor regulatory updates, helping you remain compliant, audit-ready, and globally competitive.

At MCS Associates, our audits go beyond compliance as they identify root causes, mitigate risk, and build a culture of continuous quality improvement.

Our Audit Offerings Include:

• GMP Compliance Audits (Internal, Mock, or 3rd-Party)
• Pre-Inspection Readiness Audits (Health Canada, FDA, MDSAP)
• Vendor and Supplier Qualification Audits (Domestic & International)
• Contract Manufacturer (CMO) Audits
• Remediation and Follow-Up Audits
• Data Integrity Audits (ALCOA+)
• Custom Audit Programs for multi-site operations

Every audit is backed by a detailed report outlining findings, risk ratings, and corrective/preventive action (CAPA) recommendations.

Our clients work in complex, regulated environments—and they rely on us for clarity, speed, and deep regulatory insight. MCS Expert Auditors have interdisciplinary knowledge that spans lab systems, manufacturing systems and regulatory requirements. Here’s what sets us apart:

• Cross-Industry Expertise: We understand the unique regulatory expectations for each product category—from drug APIs to cosmetic preservatives to dietary ingredients.
• Qualified Auditors: Our auditors have decades of combined experience across Quality, Regulatory Affairs, Manufacturing, and Validation.
• Global Reach: We support international audits across North America, Europe, and Asia, ensuring global supply chain compliance.
• Tailored Deliverables: We provide risk-based audit reports, gap assessments, and remediation plans aligned with your corporate quality objectives.
• Inspection Readiness: Whether you’re preparing for a Health Canada inspection, FDA visit, or ISO recertification, we act as your front-line quality partner.

A comprehensive GMP audit with a certified GMP auditor can identify GMP compliance gaps and quality issues well before they become business risks.  With certified GMP auditors, we provide a thorough evaluation of all mission-critical operations and associated documentation processes that span the entire production process from material receipt to release, distribution and post-market surveillance. At every step along the way we provide economical, efficient and pragmatic recommendations for improvement to enhance your quality management system.

Whether you’re qualifying a new supplier, preparing for a regulatory inspection, or navigating a post-inspection response, MCS Associates is here to help.

Contact us today to learn how our GMP audit services can reduce compliance risk, elevate supplier performance, and ensure regulatory success—across all your facilities and partners.