Regulatory Compliance Remediation

META Solutions provides the expertise to develop comprehensive remediation plans, as well as the experienced consultants to implement the plans and correct regulatory compliance problems. Companies worldwide have employed our remediation services to resolve serious issues resulting from FDA warning letters and consent decrees pertaining to operations ranging from preclinical to manufacturing. We have performed process reengineering, prospective validation and retrospective evaluation of computerized systems, development of SOPs and user and technical documentation, qualification of laboratory equipment, quality control of clinical data, data migration planning and implementation, and regulatory training.

Global Expertise

  • Experience with the European Agency for Evaluation of Medicinal Products (EMEA), the Medicine and Healthcare Products Regulatory Agency (MHRA), the Food and Drug Administration (FDA), and the Japanese Ministry of Health, Labor and Welfare (MHLW)
  • Extensive experience in Europe, USA, Canada, Asia, the Middle East, Central and South America, Australia and Africa

Remediation Planning and Monitoring

Our Regulatory Compliance Assessments and Vendor Audits result in recommendations for correction. The META Solutions Project and Quality Planning methodology has been successfully used to assure completion of the identified remediation tasks and sub-projects. Our consultants have assisted firms in assuring that all regulatory compliance issues are adequately resolved through a structured process of planning, progress monitoring and reporting.

Quality Management and Compliance Consulting Services

The META Solutions Regulatory Compliance Remediation Services includes general Quality Management and Compliance Consulting to assist companies with the remediation of quality management processes, procedures and controls. Our trained and experienced consultants can provide expert reviews of validation strategies, development methodologies, company policies, procedures and techniques. We can either provide recommendations for strategic and tactical improvements in policies, procedures and documentation, or assist in your remediation efforts.

GMP Remediation

  • Resolution of Warning Letter Issues
  • Failure Investigations
  • Process and Control System Remediation
  • Corrective and Preventative Action Plan (CAPA)
  • Process Validation
  • Complaint Systems
  • Consent Decree Remediation
  • Resolution of Untitled Letter Issues for CMCs
  • Outsourced Partners
  • SOP Development
  • Training

Pharmacovigilance Remediation

  • Resolution of Warning Letter Issues
  • Root Cause Analysis of SAE Late Reporting
  • Computer Systems
  • Complaint Systems Interfaces With Adverse Event Reporting Systems

GLP Remediation

  • Resolution of Warning Letters
  • Computer Validation
  • SOP Development
  • Training
  • Lab-based and University-based Sites

Quality Assurance Retainer

META has developed a number of retainer agreements in providing quality assurance services to clients.

Virtual Companies

META has extensive experience in assisting virtual companies in the remediation of their distributed facilities, partners, and contract sites.

GCP Remediation

  • Resolution of Warning Letters
  • Resolution of Untitled Letters
  • Fraud Investigations
  • Computer Validation
  • SOP Development
  • Training
  • Clinical Site Investigators
  • Universities
  • IRB Remediation

Outsourcing Partners

META has extensive experience working with companies in providing remediation at outsourced partners, including:

  • Contract Manufacturers
  • Contract Packagers
  • Contract Laboratories
  • Contract Research Organizations

Pre-approval Inspections

META can help you prepare for pre-approval inspections at:

  • Your Site
  • Contract Manufacturers
  • Contract Laboratories
  • Active Pharmaceutical Ingredient Suppliers

Representative Projects

Adverse Events System Validation Protocol and Consulting
Developed a validation protocol for a global adverse events system. This project also involved performing “discovery” activities of poorly documented activities, recommending the development of specific additional technical documentation, and advising senior management on the risks attendant to the use of the respective system.

Clinical Trials Management System Validation
Developed and executed a validation protocol for a global clinical trials management system. This project also involved performing “discovery” activities of undocumented functionality and developing required user and technical documentation.

Management of Validation Project
Assisted management in controlling the validation effort for a major document management system. The activities performed include: confirming completion of documentation by developers; coordination review process with business owner and QA; developing applicable project-specific validation standards, procedures, etc.; reviewing project deliverables to confirm compliance with applicable validation SOPs and guidelines; controlling the completeness and accuracy of the validation file; and consulting with project team members regarding validation requirements and expectations.

Toxicology System Acceptance Testing Development
Developed acceptance testing protocol and scripts for a large multi-national pharmaceutical company in order to test a comprehensive, integrated toxicology data management, project management, and study reporting system. The assistance included development of a formal requirements document, review and evaluation vendor documentation, and interviews with affected personnel.

Research Quality Assurance Application
We have developed generic and custom-built Quality Assurance systems using Visual Basic and Oracle for automating the functions of the Quality Assurance Unit. These systems are used for the entry of study information, inspection and audit finding data, and regulatory information. In addition, these systems can be used to produce the Master Schedule and other reports. We performed the system design, development, programming, validation, documentation and training for these systems.

Regulatory Contacts and Correspondence System
System used to maintain detailed information regarding FDA and sponsor communications, and the physical location of the communications and the regulatory submissions. This system was developed using INGRES database management system software on a DEC VAX computer system. It includes data entry and retrieval screens, query facilities, complex standard report facilities, and on-line help. The system was also designed to incorporate imaging technologies. The project included needs analysis, software specification, software development, testing, and user documentation and training.

Regulatory Document Index and Tracking System
This system is used to maintain detailed information and abstracts regarding regulatory submissions and pre-submission product files. Includes complex data entry screens, numerous standard reports, query facilities and on-line help. We developed the system using Oracle 6.0 database management system software on a DEC VAX computer system. The project included extensive needs and requirements definition, software specification, software development, acceptance testing, user documentation and training.

 META Solutions applies its expertise in a practical and logical way to help companies worldwide. We continually strive for innovation and we share our principles and practices through training, presenting, and publishing. We develop services and creative offerings that provide new and more efficient ways for our customers and their vendors, suppliers, and service providers to conduct their business both within regulatory compliance and with reduced risk. We are prepared to achieve the same results for you.