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GxP Compliance Consulting

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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.

Clinical trials produce vast amounts of sensitive and high-quality data, which requires an efficient data management solution that covers all aspects. To ensure that the research’s conclusions are well-supported, the clinical data management system must guarantee that the collection, availability, and integration of data meet appropriate quality standards and are within the stipulated cost.

Clinvigilant  EDC  seamlessly transforms data recorded on paper into an electronic case report form (eCRF), that can be used  for both simple and complex trials in all phases of the research.

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.

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.

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.

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.

We are always available for a conversation.

Let's discuss