gxp audits, consulting & inspections
Ensuring GxP Compliance Across All Regulatory Phases
1,000+ Audits Performed in the Last Two Years
200+ Clients Served in the US and Internationally
350+ Compliance Auditors Located in 30+ Countries
33 Languages Supported
Global Auditing Program
Auditing is an integral part of the GxP landscape as companies must be compliant with regulatory requirements to move to the next phase of development and maintain their place in the market. ProPharma serves as an extension of your clinical and commercial quality departments, collaborating closely to evaluate internal and vendor systems for compliance and quality improvements.
Enhance your quality and compliance journey with our global team of dynamic auditors. Whether you require single audits or comprehensive vendor management programs, we deliver bespoke audit support that meets your specific needs. Our expertise spans across all regulatory lifecycle stages, ensuring alignment with the latest industry trends, evolving regulations, and standards in GxP auditing.
GxP Consulting & Audit Services
With a wealth of experience, our auditors specialize in conducting a wide range of audits and assessments. From comprehensive compliance audits to assisting with health authority inspections and pre-approval preparations, we provide comprehensive support throughout the audit process.
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With offices and compliance consultants located around the world, ProPharma offers the capability to execute audits in different GxP areas on a global scale, ensuring GxP compliance and creating efficiency and savings. Our large team of qualified auditors has a breadth of expertise across the entire development and regulatory spectrum, including the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), United States Food and Drug Association (FDA), Japan Pharmaceuticals and Medical Devices Agency (PDMA), Health Canada, ISO-13485, ISO-9001, CAP/CLIA, Computer Systems Validation (CSV), Digital Compliance Audits, and Data Integrity.
GxP Compliance & Vendor Audits
Vendor audits are critical to maintaining GxP compliance throughout the supply chain, and ProPharma specializes in providing tailored vendor audit services that encompass a wide range of suppliers and service providers. Our expert auditors conduct thorough evaluations of suppliers' quality management practices, covering critical aspects such as manufacturing processes, quality control measures, clinical trial management, and pharmacovigilance activities. By thoroughly assessing processes, documentation practices and regulatory compliance across these service areas, we identify potential risks and areas for improvement, empowering our clients to make informed decisions in vendor selection and management. With ProPharma's comprehensive expertise, organizations can navigate vendor management complexities with confidence, ensuring GxP compliance and upholding the highest standards of quality and integrity.
Good Manufacturing Practice (GMP) Audits
We offer comprehensive cGMP (Current Good Manufacturing Practice) compliance audits tailored to your specific needs, whether it's for an initial qualification of your vendor or recurring audits. Our highly experienced team conducts audits with a focus on independence and impartiality, providing you with valuable insights and actionable recommendations for improvement. We specialize in conducting audits across various GMP industries, including:
- Drug product/drug substance
- Medical devices and diagnostics
- Excipients and raw materials
- GDP – warehouse and distribution
- GMP laboratories
Good Clinical Practice (GCP) Audits
ProPharma's GCP (Good Clinical Practice) Auditors specialize in conducting thorough and comprehensive GCP Audits, offering assurance that your clinical studies, whether ongoing or planned, are conducted in compliance with regulatory requirements. Our audits provide valuable insights and recommendations to ensure clinical study compliance success. We focus on various key areas, including:
- Clinical Research Organization (CRO)
- Investigator Sites
- Trial Master Files (TMF)
- Good Clinical Laboratory Practice (GCLP)
IT Vendor Audits
Regulators require assessment and approval for suppliers of critical software applications, IT infrastructure, and IT support services. ProPharma has the expertise to assess system functionality and vendors’ quality management practices for compliance with regulations such as Part 11 and Annex 11. Additionally, we assess your IT vendor’s SDLC and testing methodologies so you will have the documentation to support your computer system validation strategy. Our audit services include:
- Software, SaaS, and PaaS vendor audits
- IT infrastructure and IaaS vendor audits
- IT service and validation provider vendor audits
Good Laboratory Practice (GLP) Audits
ProPharma specializes in conducting comprehensive GLP (Good Laboratory Practice) Audits, ensuring that pre-clinical and clinical laboratory activities are appropriately managed and comply with regulatory requirements. Our audits cover a wide range of areas, including animal studies, toxicological assessments, pharmacokinetics (PK) studies, and clinical laboratory specimen testing. Our experienced auditors identify potential areas for improvement, ensure the welfare of laboratory animals, and verify the accuracy and reliability of laboratory data. We focus on various key components of GLP auditing, including:
- Nonclinical labs
- Animal use and care
Postmarket Surveillance Audits
ProPharma’s Postmarket Surveillance Audits evaluate the intake of drug and medical device / diagnostic safety data, compliance with reporting requirements, and adherence to timelines. Our audits focus on key areas within post-market surveillance, and our team provides detailed assessments to ensure regulatory compliance and enhance patient safety. Our expertise covers the following aspects:
- Pharmacovigilance (PV)
- Complaint management
- Digital Information and Internet Systems (IT/IS)
Inspection Readiness
Our inspection readiness auditing encompasses pre-approval inspection (PAI) readiness or mock inspection and gap analysis prior to the inspection by a regulatory agency. Our team of inspection readiness auditors has experience with over 60 regulatory inspections undertaken by various agencies including the MHRA (UK), HPRA (Ireland), EMA, SUKL (Czech Republic), FDA (US), Korean FDA, Turkish MOH, MCC South Africa, Anvisa Brazil, at sites in Argentina, Bangladesh, Czech Republic, England, India, Nordics, Belgium, Germany, The Netherlands, Switzerland, and Ireland.
Our Inspection Readiness Services Include:
- Pre-Approval Regulatory Inspections in all GxP areas: Ensuring your organization is fully prepared for regulatory assessments
- Mock Regulatory Inspections in all GxP Areas: Practicing simulated inspections to identify and address potential issues proactively.
- Guidance on Corrective Actions: Providing insight into necessary corrective actions and validations before the regulatory inspection, avoiding potential non-compliance citations.
- Training for Successful Regulatory Inspection: Preparing your team for interviews, interactions, and best practices during regulatory agency visits.
- Inspection Readiness Reviews: Crucial, especially with the increasing frequency of unannounced inspections.
- Compliance-Level Review for License Applications: Assessing compliance with best practice standards for obtaining or retaining essential licenses like Manufacturer's/Importation Authorisation (MIA), Wholesale Distributor Authorisation (WDA), Marketing Authorization (MA), GMP, and GDP.
Ensure your organization is inspection-ready with our comprehensive audit services, tailored to meet your GxP compliance needs and ensure seamless interactions with regulatory agencies.
Quality Management System Gap Assessments
Providing a risk-based "right-sized" approach, our compliance experts evaluate the current state of an organization’s Quality Management System for compliance with regulatory requirements and best industry practices. Our compliance experts will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and can work side-by-side with you to implement improvement plans and support your staff in addressing those risks.
Data Integrity Gap Assessments
ProPharma assesses real-world situations vs. the principles of ALCOA to identify data integrity risks. We have drawn from international regulations, regulatory guidance documents, FDA Warning Letters, and decades of professional experience to develop comprehensive tools for assessing policies, procedures, and systems to detect data integrity risks. Our standardized approach to performing data integrity gap assessments encompasses the requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.
Our mission is to provide the information you need to mitigate data integrity risks before your organization has a data integrity issue.
Other Audit Services
Return To Service Audits
When our clients seek assistance in remedying regulatory agency actions, such as a warning letter, ProPharma recommends a multi-stage approach. Warning letters are typically issued by agencies when they perceive a lack of control in healthcare products manufacturing. As part of the remediation process, the company is expected to evaluate the state of compliance across the entire organization and remediate all observed compliance issues. ProPharma’s approach involves conducting comprehensive GMP Baseline Assessments across 31 Quality System Elements (QSE) that roll up to the six-systems inspection methodology.
Due Diligence
ProPharma's Quality & Compliance team possesses extensive expertise in conducting Due Diligence audits for firms undergoing mergers or acquisitions. These audits involve comprehensive assessments of the target companies' quality systems to evaluate their current state and provide a thorough measure of the risk associated with potential compliance faults.
Our auditors carefully examine various aspects of the target company's operations, including quality management systems, standard operating procedures, documentation practices, training programs, and regulatory compliance records. By conducting these assessments, we enable clients to gain a comprehensive understanding of the target company's compliance status, potential risks, and areas that require remediation.
We focus on identifying any compliance gaps or deficiencies that may impact the integration process. Working collaboratively with our clients, we develop effective mitigation strategies. Leveraging our expertise and attention to detail, we assist our clients in mitigating compliance risks, optimizing their due diligence process, and ensuring a seamless transition during mergers or acquisitions.
Internal Audits
Our experienced auditors can also help companies evaluate and improve their internal controls and GxP compliance. We review policies, procedures, and documentation, analyze risk management practices, and conduct interviews with key personnel. We collaborate closely with clients, offering actionable recommendations and assisting with corrective action plans. With ProPharma's expertise, organizations can strengthen their internal processes and achieve operational excellence.
Request an AuditMedical Device & Diagnostics
At ProPharma, we understand the unique challenges faced by medical device and diagnostic companies in maintaining compliance with regulatory requirements across different regions, including the European Medical Device Directive (MDD). Our specialized team of auditors offers comprehensive auditing services tailored specifically to the needs of medical device and diagnostic manufacturers on a global scale.
With our global reach and expertise, we provide auditing services that encompass every aspect of medical device and diagnostic manufacturing, including design controls, manufacturing processes, quality management systems, and post-market surveillance. Our auditors are well-versed in international regulations and standards, ensuring that your products meet the necessary requirements for market approval and distribution worldwide.
Understanding the FDA's initiative to align the QSR (21 CFR 820) more closely with ISO 13485, we stay abreast of regulatory updates and industry trends to ensure that our auditing services are always up-to-date and in line with the latest regulatory expectations. Whether you're a startup launching your first medical device or a multinational corporation expanding into new markets, our auditing services are designed to help you navigate the complexities of regulatory compliance with confidence. By partnering with ProPharma, you can ensure that your medical devices and diagnostics meet the highest standards of quality, safety, and GxP compliance, enabling you to bring innovative healthcare solutions to patients around the globe.
Our GxP Audit & Consulting Approach
ProPharma's Quality & Compliance consultants provide a foundation of quality expertise across the landscape of regulatory expectations. We bring established quality processes to quickly navigate compliance solutions and assessment of risk to help identify, build, and maintain compliance to the ever-changing regulatory expectations. Our dedicated team of subject matter experts works to ensure that each individual project is successful.
Audit Preparation
Audit Execution
Post Audit Deliverables
Audit Coordination Team
Each client is aligned with a dedicated Audit Coordinator, serving as the point of contact who will facilitate the management of audit logistics, periodic progress meetings, timelines, and completion of deliverables between client/sponsor, auditor, and auditee.
We'll also assign a subject matter expert (SME) compliance consultant who will serve as technical support for audit process and peer review of deliverables and outputs.
GxP Auditor
Assigned on a per audit basis, we’ll match you with an auditor who has the background, experience, and expertise aligned with the audit scope, geographic location, and project timing.
The assigned auditor(s) will be trained on any relevant Standard Operating Procedures (SOPs) of the client when requested.
Audit Preparation
Audit scope and timelines will be agreed upon with the client. As required, Sponsor procedures and templates may be used for audit preparation, conduct, and follow-up.
A briefing meeting to ensure full alignment with client in case of specific requirements may be part of the preparations.
An Agenda / Plan will be developed to formally agree upon the audit details (purpose, scope, criteria, activities, etc.) with client.
Virtual / On-site Audits
ProPharma has extensive experience performing both in-person and virtual audits. In the event of virtual audits, our audit coordination team provides an additional level of technical support to ensure that document sharing, application access, and web conferencing are aligned prior to audit onset to avoid delays.
Audit Scheduling
ProPharma utilizes a validated audit scheduling database to ensure that all audits and deliverables are managed to client timelines and expectations.
The audit dates and plan will be confirmed with the vendor (e.g., Clinical Research Organizations (CRO), laboratory, manufacturer, etc.).
For preparation purposes, some documents may be requested from the site and/or Client prior to the assessment.
Audit Execution
During the Audit Execution phase, we execute the audit according to the agenda/plan. This includes reviewing roles and responsibilities, conducting facility tours, interviews, material reviews, and daily debrief meetings.
We analyze observations, make recommendations, and identify areas of positive performance.
Our auditors follow a specific audit execution methodology for the appropriate GxP type and lifecycle stage.
Peer Review
ProPharma's team of compliance consultants will perform a technical and quality peer review of all deliverables prior to submittal to the client to ensure consistency and compliance accuracy.
Deliver Final Report
A final report will be drafted based on a pre-determined format agreed upon with the client.
Debrief Meeting
A debriefing meeting with the Client following the assessment may be part of the arrangements.
Deficiency Classification
Deficiencies are typically categorized as critical, major, or minor. Comments or recommendations may be included in the report, including recommendations to ensure compliance or inspection readiness of the auditee. The responsibility for addressing the finding (sponsor/CRO, investigator, vendor, etc.) may also be included.
Post Audit Support & CAPA Management
ProPharma offers Post Audit Support and CAPA Management services to assist clients in resolving CAPA items identified during audits. Our expert consultants provide administrative support by tracking and compiling CAPA commitments, conducting auditor adequacy reviews, and offering CAPA remediation assistance. We ensure regulatory compliance, address root causes, and drive continuous improvement.
Audit Preparation
Audit Coordination Team
Each client is aligned with a dedicated Audit Coordinator, serving as the point of contact who will facilitate the management of audit logistics, periodic progress meetings, timelines, and completion of deliverables between client/sponsor, auditor, and auditee.
We'll also assign a subject matter expert (SME) compliance consultant who will serve as technical support for audit process and peer review of deliverables and outputs.
GxP Auditor
Assigned on a per audit basis, we’ll match you with an auditor who has the background, experience, and expertise aligned with the audit scope, geographic location, and project timing.
The assigned auditor(s) will be trained on any relevant Standard Operating Procedures (SOPs) of the client when requested.
Audit Preparation
Audit scope and timelines will be agreed upon with the client. As required, Sponsor procedures and templates may be used for audit preparation, conduct, and follow-up.
A briefing meeting to ensure full alignment with client in case of specific requirements may be part of the preparations.
An Agenda / Plan will be developed to formally agree upon the audit details (purpose, scope, criteria, activities, etc.) with client.
Audit Execution
Virtual / On-site Audits
ProPharma has extensive experience performing both in-person and virtual audits. In the event of virtual audits, our audit coordination team provides an additional level of technical support to ensure that document sharing, application access, and web conferencing are aligned prior to audit onset to avoid delays.
Audit Scheduling
ProPharma utilizes a validated audit scheduling database to ensure that all audits and deliverables are managed to client timelines and expectations.
The audit dates and plan will be confirmed with the vendor (e.g., Clinical Research Organizations (CRO), laboratory, manufacturer, etc.).
For preparation purposes, some documents may be requested from the site and/or Client prior to the assessment.
Audit Execution
During the Audit Execution phase, we execute the audit according to the agenda/plan. This includes reviewing roles and responsibilities, conducting facility tours, interviews, material reviews, and daily debrief meetings.
We analyze observations, make recommendations, and identify areas of positive performance.
Our auditors follow a specific audit execution methodology for the appropriate GxP type and lifecycle stage.
Post Audit Deliverables
Peer Review
ProPharma's team of compliance consultants will perform a technical and quality peer review of all deliverables prior to submittal to the client to ensure consistency and compliance accuracy.
Deliver Final Report
A final report will be drafted based on a pre-determined format agreed upon with the client.
Debrief Meeting
A debriefing meeting with the Client following the assessment may be part of the arrangements.
Deficiency Classification
Deficiencies are typically categorized as critical, major, or minor. Comments or recommendations may be included in the report, including recommendations to ensure compliance or inspection readiness of the auditee. The responsibility for addressing the finding (sponsor/CRO, investigator, vendor, etc.) may also be included.
Post Audit Support & CAPA Management
ProPharma offers Post Audit Support and CAPA Management services to assist clients in resolving CAPA items identified during audits. Our expert consultants provide administrative support by tracking and compiling CAPA commitments, conducting auditor adequacy reviews, and offering CAPA remediation assistance. We ensure regulatory compliance, address root causes, and drive continuous improvement.
Meet Our GxP Experts & Consultants
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James Meckstroth
Senior Director, Compliance & Quality Assurance
View Bio
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Laurie Rouse
Senior Global Audit Coordination Manager
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Catrin Jones
Consultant, Compliance and Quality Assurance
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Matt Hermon
Principal Compliance Consultant
Customized Strategy. Globally Scaled Solutions.
ProPharma's ability to execute audits in different GxP areas on a global basis with diverse language skills creates efficiencies in both time and money. Our experienced team of qualified auditors from around the world is here to support the entire development and regulatory spectrum.
News & Insights
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News & Insights
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 30, 2024
ProPharma Names Dawn Sherman Chief Executive Officer
Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.
