Pharmaceutical & Medical Device

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We are experts. Attadale presents an expert group of practitioners experienced implementing global operational improvement programs for some of the largest Life Science companies in the world.

Accelrating risk and complexity in NCE and device performance is rewriting the operating model. As the pace of mergers and consolidation increases, both for scale and to renew product pipelines, our clients continually seek operation improvements to reduce costs, accelerate integration and to maintain quality and regulatory compliance.

Our staff of experts have proactively lead through enhanced quality and regulatory standardization to streamline processes, aid operational integration, enhance data mining capabilities and improve regulatory compliance. Below are some examples where we have designed and implemented global solutions:

Corrective and Preventive Actions

We have implemented CAPA processes and supporting tools to improve identification analysis and management of CAPA events.

Validation Management

Attadale has experience designing and implementation processes to standardize protocols, improve scheduling and tracking oif validation activities, and provide real-time reporting and tools.

Complaints Management

Developed a standardized approach to global complaints management that increased the efficiency and completeness of processing, defined global regulatory reporting requirements, and developed a data mining capability for improved causal analysis.

Electronic Document Management (including NDA and other regulatory filings)

End-to-end design and implementation of document management solutions

Phase Zero Requirements Analysis

Develop business requirements, including process, organization and reporting requirements to support a myriad of internal business decisions such as business process outsourcing assessment.

Attadale has broad experience implementing change in Life Science companies. To retain our services or to learn more about our capabilities and experience, contact us at info@attadalepartners.com or our North American headquarters at 847.330.6310