GxP Compliance Consulting
In order to comply with Good Practice guidelines (GxPs), customers must guarantee independent quality management. We offer assistance in building or revamping your QMS and provide access to global resources.
Overview of Our Quality and Compliance Consulting Services
Assessing potential risks and issues early in the product development life cycle is a must. Our Quality and Compliance team is dedicated to evaluating and managing quality and risks programs, leveraging our knowledge of inspection agencies. We are here to assist you in managing your risk effectively.
Compliance Audits - Complete Independence
We offer the following types of audits: investigator site, vendor, for cause, TMF, database, document, safety/PV, central lab, GMP and IRB. We also offer assessment and effectiveness audits of QMS, investigations and RCA, training programs, and CAPA process.
Identification and Management of Compliance Risk for External Customers
Our global quality consulting team provides individual compliance audits as well as total quality and compliance program management, as an extension of our customers.
Quality Management – Effective Quality Systems and Processes and Organizational Regulatory Compliance
We can provide process and operating model optimization, operational effectiveness, change management and communication, and implementation of new regulatory requirements within a company’s QMS.
Inspection Readiness - Mock Inspections
We can conduct mock inspections for investigator sites, partners and customers, and inspection readiness activities, including audit or regulatory documentation and verification of preparedness. In addition, we offer investigator training and responsible team training.
Completely Independent Study Operations and Corporate Quality Capabilities
Quality audit
Investigator site, vendor qualification and performance, data management, pharmacovigilance, clinical and statistical reporting, TMF and GxP system.
GMP auditing
We can provide vendor auditing and management, and site audits.
We also offer batch record review and release, GMP/GLP inspection readiness (in line with both FDA and EMA regulations), risk-based quality assessments and GAP analysis, and compliance remediation.
GPV Support
Global PV Unit (RPV) and local affiliates (local RPV)
Our GPV support includes organizational structure, personnel qualifications, training and experience; vendor oversight; quality management system (including procedural deviations, audits, CAPAs); EU QPPP responsibilities; PSMF management; management of cases: data collection, assessment, medical review; safety event sourcing (medical enquiries, call centers, sales representatives, literature reviews, clinical studies, customer engagement programs, etc); product complaints; signal detection; aggregate reporting; business continuity plans; updates of reference safety information and management of safety restrictions (e.g., SmPC transmission, core data sheet update, labeling); and safety reporting to authorities.
PV Unit interaction with third parties
These include vendors, CROs, alliance partners, co-licensing partners and distributors.
We Are Part of Your Team
We are quality specialists who have completed thousands of audits, inspections and implementations across every corner of the globe. We are also consultants with diverse backgrounds across management consulting, corporate strategy, product development, strategic finance and venture capital. And, we are regulatory experts, including veterans of the FDA and the world’s largest biopharmaceutical companies. But, most importantly, we are part of your team.
