Contact us to discover how our Global Audit Program can help support your needs.
ECI delivers expert, full-service auditing and compliance solutions for the pharmaceuticals, biotechnology, medical devices, diagnostics, and cosmeceuticals. Our global team includes former FDA and Notified Body experts, industry veterans, and specialized consultants who deliver tailored solutions across auditing, remediation, QMS optimization, regulatory strategy, and training. Whether preparing for inspection, navigating post-market challenges, or strengthening your compliance systems, ECI brings technical depth, global perspective, and practical support to every project.
We deliver value-driven audits worldwide. Whether you need a single audit or a trusted third-party provider for all your internal and supplier audits, ECI can handle it all. Our audits are led by seasoned auditors, supported by dedicated project managers, and backed by regulatory experts committed to your compliance success.
Evaluate the effectiveness of your internal quality system processes to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable country-specific regulations.
Assess your suppliers’ compliance with quality and regulatory requirements, helping mitigate supply chain risks and maintain product quality throughout the lifecycle.
Simulate an FDA inspection to identify potential nonconformities before regulatory bodies do. Ideal for audit readiness and stress-testing internal controls.
Analyze your current systems against evolving regulatory expectations (QMSR, EU MDR, MDSAP, etc.) to uncover compliance gaps and prioritize remediation efforts.
Evaluate your organization’s readiness for the Medical Device Single Audit Program by assessing conformance with the requirements of multiple regulatory authorities through one comprehensive audit framework.
Support your organization across all phases of M&A, before, during, and after a transaction, by delivering due diligence services that uncover compliance gaps, regulatory risks, and post-integration complexities.
(Good Practice - GxP): Assess compliance with global GxP standards to ensure consistent manufacturing, product safety, and regulatory adherence in pharma and biotech operations.
(Good Clinical Practice): Evaluate clinical trial operations, documentation, and site compliance to protect patient rights and ensure the integrity of study data.
We assess your organization’s compliance with U.S. Drug Enforcement Administration (DEA) regulations for controlled substances. This includes evaluating handling procedures, recordkeeping, inventory control, and site security to ensure readiness for DEA inspections and licensing requirements.
(Computer System Validation) ensure that computerized systems used in pharmaceuticals are compliant with regulations and fit for their intended use. We assess system integrity, data security, and reliability for full GxP compliance.
Whatever your compliance challenge, our team can design and execute a value-driven audit program that delivers actionable insights and strengthens your regulatory readiness.
Contact us to discuss how our experienced regulatory, quality, and engineering teams can support your organization throughout the product lifecycle.
Your Trusted Partner in Life Sciences Compliance and Quality
Our Global Audit Program has supported life sciences clients in strengthening compliance, mitigating risk, and preparing for regulatory inspections across North and South America.
Simulated FDA audit of a medical device manufacturing site to validate inspection readiness, reinforce internal controls, and address high-risk areas before the actual visit.
Comprehensive internal audits for sites in New Hampshire and New York, evaluating compliance to ISO 13485 and FDA 21 CFR Part 820, and supporting ongoing QMS improvement efforts.
A 2-day onsite GCP Investigator Site Audit helped a clinical research site in Brazil prepare for sponsor and regulatory inspections, identifying critical gaps in documentation and subject safety protocols.
Our team conducted a 2-day onsite GxP audit of a key pharmaceutical supplier in Florida, uncovering quality system gaps and providing a prioritized remediation roadmap aligned with 21 CFR Part 211.
A 1-day DEA gap assessment at a specialty pharmacy in Texas focused on controlled substance handling, inventory security, and regulatory reporting, ensuring readiness for DEA registration and inspection.
We collaborate with your team to develop corrective action plans that address identified issues and improve overall compliance.
Our experts provide ongoing support throughout the remediation process, ensuring that all corrective actions are implemented effectively and in full compliance with applicable laws and regulations.
Our dedicated and experienced project managers save you time by managing every aspect of your audit from start to finish.
Whether it is an internal or supplier audit, our team begins with a kick-off call to review scope, gather the necessary documentation, assess procedures, and provide a detailed plan to ensure your organization is fully prepared for a comprehensive audit.
Our auditors will conduct your audit according to the agreed scope and expectations provided, addressing any areas of concern. We ensure continuous communication with you and your team throughout the audit, particularly if any concerning findings are identified.
Upon completion of the audit, you will receive a peer-reviewed draft report detailing the audit results, including any non-conformances, gaps, and opportunities for improvement, while ensuring compliance against applicable standards and regulations.
Our project managers will facilitate the electronic signing of the final audit report in compliance with Part 11 regulations. Once signed, the report will be distributed to all approved parties.
ECI’s auditors bring specialized knowledge across a wide range of GxP areas, supported by former FDA professionals and industry experts with extensive regulatory expertise.
Yes. We tailor our services to your requirements, assigning the right team members at each stage of the project, whether for immediate remediation or long-term compliance support.
Absolutely. Our international team of auditors possesses a range of language skills and cultural knowledge, ensuring seamless communication and understanding across global markets.
Partnering with ECI provides immediate relief by allowing your internal team to focus on their core competencies and daily responsibilities, boosting efficiency and productivity across the organization. Beyond the engagement, we ensure seamless knowledge transfer and share best practices with your team, strengthening their capabilities and creating a lasting positive impact long after our assignment is complete.
From preparation to report delivery, our transparent fixed-fee pricing ensures no hidden costs or unexpected change orders, which gives you peace of mind and financial clarity.
In most cases, we can begin right away. This swift response is essential for addressing regulatory agencies, implementing remediation plans, and keeping progress on schedule.
Yes. Many of our auditors have direct experience with the FDA and other regulatory agencies, providing independent, impartial guidance throughout your compliance process.
Contact us to discover how our Global Audit Program can help support your needs.
