META’s principal consultants possess a thorough and practical understanding of international regulatory requirements and expectations. They also have expertise in a broad range of preclinical, clinical, and manufacturing operations. Together, this knowledge and experience enable us to efficiently help clients manage regulatory compliance risk for optimal outcomes. We identify non-compliant areas, assess risk, likelihood and potential impact of losses that would result from non-compliance, and develop solutions, guidance, and training to minimize the likelihood of such losses.

Expertise

The key to the success of our Regulatory Compliance Consulting Services is our extensive knowledge of the pharmaceutical industry and regulatory requirements, and our experience in identifying and delivering effective and regulatory-compliant solutions. Our broad experience includes the performance of regulatory consulting services for numerous clients that include pharmaceutical companies, biotechnology firms, medical device companies, Contract Research Organizations (CROs), software vendors, and Application Service Providers (ASPs).

Regulatory Compliance Training Services

META Solutions offers Regulatory Compliance Training Services that can help your company and team members obtain a detailed understanding of critical regulations and methods of applying them to particular systems and processes. We have performed Regulatory Compliance Training sessions on a variety of topics including, but not limited to:

• 21 CFR Part 11 Regulations and Guidance
• FDA and ICH Good Clinical Practices Regulations and Guidance
• Electronic Document Management and Electronic Submissions
• Good Laboratory Practices
• Effective and Practical Computer Systems
• Validation

Regulatory Compliance Assessment

META performs detailed Regulatory Compliance Assessments of pharmaceutical, biotechnology, and medical device companies, CROs, ASPs, and product vendors to determine the regulatory compliance of systems, procedures, documentation, and controls. We have a standardized and highly successful process that consists of interviewing key users, developers, quality assurance, support, and operation and management personnel who are involved with the respective computerized system(s) and processes. We also perform detailed assessments of the regulatory compliance of system documentation, study records, and relevant information in accordance with regulations, guidelines, and expectations.

Remediation Planning and Monitoring

Our Regulatory Compliance Assessments and Vendor Audits often result in numerous findings and recommendations for remediation. The META Solutions Project and Quality Planning methodology has been developed and successfully utilized to assure the comprehensive and thorough completion of the identified remediation sub-projects and related activities. Our consultants have assisted both sponsors and vendors in assuring that all regulatory compliance issues are adequately resolved through a structured process of planning, progress monitoring, and reporting.

Vendor Auditing

META Solutions has performed numerous audits of vendors of software products, contract service companies, technology service providers, clinical laboratories, and data management organizations on behalf of our domestic and global pharmaceutical, biotechnology, and contract laboratory clients. The audits were performed to determine the level of compliance with local regulations and guidance regarding computer system validation, GLP/GCP/GMP requirements, and 21 CFR Part 11, and to minimize business and technical risks to the purchaser. These audits are formally documented in Vendor Audit Reports with reference to the relevant regulations and guidance, and include extensive and detailed recommendations for corrective action.

Quality Management and Compliance Consulting Services

The META Solutions Regulatory Compliance Consulting Services include general Quality Management and Compliance Consulting to assist companies with the development or improvement of quality assurance, quality control, and 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 our recommendations in a formal report that provides strategic and tactical improvements in policies, procedures, and documentation, or our trained personnel can write missing or deficient quality management documents.

Representative Projects

Biotech Corporate Validation Strategy Development
Assisted the management of a biotechnology company in the development and implementation a corporate-wide validation strategy.

• GLP Mock Inspection
  Performed a mock inspection of a Japanese pharmaceutical company in anticipation of an FDA inspection. The inspection included preclinical drug safety and pharmacology facilities. The resulting inspection report provided detailed recommendations for resolving compliance deficiencies regarding personnel training, SOPs, laboratory operations, security, computer systems, archives and data management.
• SOP Gap Analysis
  At a corporate level for a major pharmaceutical company, we identified specific deficiencies regarding SOPs, provided detailed recommendations to address these deficiencies, provided resource estimates to address the deficiencies, and provided additional recommendations relating to restructuring the SOP administration function, training, continuous improvement, and using an SOP database.
• Compliance Consulting
  Evaluated compliance of a major company with Good Laboratory Practices Regulations from EPA and from the Organization for Economic Cooperation and Development (Field). The assistance included reviewing the compliance strategy and approach and results of several pilot validation projects, and recommending enhancements to policies, procedures, techniques, etc.
• Vendor Audit
  Performed an audit of vendor of a comprehensive, integrated toxicology data management, project management, and study reporting system. The audit was performed to review systems, procedures and development documentation, and to interview key development and management personnel that are involved with the development and maintenance of the software.
• Software Development Methodology Consulting and Training
  Conducted Planning and Training sessions for in-house and vendor software development organizations that create and support software applications that are used in FDA and EPA-regulated environments. The consulting services have included the development of an appropriate software development methodology, with SOPs and documentation standards.

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.