ABPII offers high-quality, comprehensive Regulatory Compliance Consulting Services to help you identify and mitigate regulatory risks and to achieve your goals of regulatory compliance. Our experienced team can identify potential problem areas with systems, processes and documentation, offer recommendations and corrective action, perform remedial work and project management activities, and train personnel on pertinent regulations and methods.

Regulatory Compliance Assessment
ABPII performs detailed Regulatory Compliance Assessments of pharmaceutical, biotechnology and medical device companies, 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, 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 systems documentation, study records and relevant information in accordance with FDA regulations, guidelines and expectations.

Vendor Auditing
ABPII has performed numerous audits of vendors of software products, contract service companies, technology service providers, and 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 FDA regulations and guidance regarding computer system validation and to minimize business and technical risks to the purchaser. Within the audits we formally document the recommendations for corrective action, including reference to the relevant regulations and guidance.

Remediation Planning and Monitoring
Our Regulatory Compliance Assessments and Vendor Audits often result in numerous findings and recommendations. The ABPII Project and Quality Planning methodology has been successfully used to assure the complete and thorough completion of the identified remediation tasks and sub-projects. Our consultants have assisted both the sponsors and vendors 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 ABPII Regulatory Compliance Consulting Services includes 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.