Regulatory, Compliance & Product Lifecycle Management

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Assess, improve and maintain compliance while advancing operational efficiency.

Ensuring compliance and demonstrating control throughout the product lifecycle is essential for brand reputation and meeting global health authority requirements. Verista’s consultants possess a large breadth and depth of expertise and industry experience assessing and implementing compliance systems and ensuring regulatory compliance. We help define and guide clients on the optimal pathways of their approval process and ensure that all requirements are completed successfully and efficiently while directly interacting with agencies. We have the expertise to tailor support specific to your needs.

Regulatory Compliance & Support

Our team of regulatory affairs experts have a proven history of interacting with health authorities and are able to guide clients from product concept development to approval. They assist clients with defining their submission strategy, compiling their required data, and directly communicating with agencies to ensure all requirements are satisfied. Our goal is to ensure your compliance roadmap is well defined and in a state of control while following a risk-based approach.

Gap analysis efforts and regulatory strategy development.

Regulatory due diligence activities.

FDA submissions support.

Regulatory agency meetings support.

Pre-approval inspection readiness support.

Auditing, Inspection Readiness & Remediation

Our team of auditors have extensive firsthand experience with leading audit techniques and can assess quality systems and operations to verify compliance with GXP regulations. They implement internal audit and gap analysis programs, identify areas of risk for improvement, and recommend solutions that address deficiencies with a detailed findings report. They also support inspection readiness preparation, perform mock audits that identify risks and simulate actual inspections to optimize inspection management, post-inspection issue resolution, remediation, and CAPA plan development/implementation, and are well versed in direct communication with health authorities on behalf of clients.

Construction and implementation of vendor auditing programs, inspection readiness walkthrough programs and internal auditing programs.

Mock audit performance and Inspection hosting and backroom management.

Post-inspection remediation planning, issue resolution, remediation activities, regulatory response support and inspection report management.

Form 483 and warning letter remediation, and regulatory response support.

Execution and reporting of external vendor audits.

Our experts facilitate compliance by providing best-in-class solutions within the areas of regulatory, quality, auditing and product lifecycle management – from R&D to manufacturing.

Quality & Compliance

Verista’s team of experts understand and implement industry leading strategies that balance risk while delivery solutions in the most efficient manner. Their goal is to meet client needs through establishing and restructuring a best-in-class compliant and efficient Quality Management System (QMS). Our proven history of delivering tailored, client-specific QMS solutions encompass current and future state needs, all while ensuring both compliance and efficiency of the business. By assessing a client’s current risks, we reduce backlogs and return clients to a compliant state.

QMS development and remediation support.

Performance of gap analysis and data integrity & privacy assessments.

Risk assessment performance and program development.

Quality as a Service (QAAS), in-house quality assurance and sterility assurance support.

Product Lifecycle Management

Our team of engineers has expertise across small and large molecule drug development and provide guidance across the different phases of product development lifecycle. We understand the importance of quality by design, platform scalability for large scale commercial manufacturing, efficiency and compliance. Our domain specific experts tailor each project to meet the unique needs of our clients.

Technology Transfer Management: Stage gate design, CMO/vendor management, facility fit activities, process comparability and the establishment of tech transfer packages.

Product Lifecycle Management (LCM): The identification of critical quality attributes (CQAs), critical process parameters (CPPs), in-process controls (IPCs), quality by design (QbD) activities, process validation and qualification, and the performance of process gap and raw material E&L assessments.

CMC Management and analytical method development, validation and verification.

Materials, Science & Technology (MS&T): Process and product development management activities as well as change and deviation management.