Introducing CentaurAI: AI-Accelerated Regulatory Submissions
We help you ensure that phase-appropriate compliant systems are in place so your program stays aligned with "Quality by Design" principles and ahead of the curve—without wasting resources, capital, or generating excessive bureaucracy.
Our industry-experienced experts have implemented dozens of quality systems within the biopharmaceutical, pharmaceutical, medical device, and combination product industries. We assist with organizational activities, plans, policies, procedures, and processes and provide the resources to design, implement, and maintain a quality system that delivers quality, compliant drug products.
We develop and implement quality systems in accordance with:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and phase of development. Of particular interest to many of our clients is BioTechLogic's QMS in a Box.
We analyze your existing QMS, identify any gaps, and provide phase-appropriate and resource-efficient solutions to address them.
Hands-on operational quality support includes:
We write your SOPs, policies, and other controlled documents, or provide expert review and revision of existing documents.
To ensure successful inspections, we conduct a risk evaluation well in advance of your inspection window. This assessment may identify high-risk areas in your supply chain, informing an inspection readiness plan and effective resource allocation. Inspection readiness also runs to gap assessment against the FDA System Approach, European and other international regulations, or more specialty regulations, like Annex 1 for sterile drug production manufacturing, data integrity compliance, or good laboratory practices. We also plan and execute these for 3rd parties.
The generation and execution of a comprehensive phase-appropriate quality audit program is critical for regulatory and developmental success. We combine specialized in-house experience and the use of a proprietary toolkit when customizing an audit for your program. Whether preparing for and supporting an external GMP audit by a global regulator [pre-approval inspection (PAI), pre-licensing inspection (PLI)] or planning and executing an internal audit, our team offers comprehensive capabilities in support of agency audits. We also plan and execute audits of third parties (e.g., suppliers and contract testing/manufacturing sites) on behalf of client sponsors.
Common requests include:
For clients currently without internal leadership in this domain, our senior experts can provide interim expertise and hands-on leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.
Our eligible QPs are experts in global regulatory standards. Common eligible QP client requests include training and education on the roles of QP as well as QP audits and remediation.
Please contact us for further discussion should you require batch certification or licensing support.
We perform evaluations, risk assessments, and/or audits of critical raw material suppliers, contract manufacturers, and analytical service providers to ensure their quality standards are aligned with your needs.
QMS remediation addresses gaps in US, EU, and ANVISA GMP based on guidances, regulations, directives, and norms from these regions. This includes performance of a gap assessment, a subsequent report, and preparation of inspection sub-system remediation quality plans to focus work efforts and prioritization. This can apply to any or all of the six inspection subsystems: quality system, production controls, facilities and equipment, laboratory controls, materials control, and packaging and labeling.
We support comprehensive global inspection readiness remediation projects, whether a 483 remediation, clinical hold, a product complaint or adverse event, Complete Response Letter (CRL), or other.
Our team designs and implements quality system procedures and instructions in line with client objectives and the requirements of the leading regulatory bodies. Elements of our quality management system programs include the establishment and/or management of:
We oversee your project to achieve your milestones in a timely fashion, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable, consulted, informed) matrices, and following up on achievement of action items.
We assist companies by supporting the registration of drug-device combination products; our team can guide you through the matrix of requirements. The following are examples of services to help support combination products throughout product development and into commercialization:
To provide support for a remediation or to ensure future compliance, we offer customized teach-ins.
.png)
