Our associates have nearly two and a half decades of experience as Life Sciences industry professionals, providing third‐party oversight, process development, process improvement, change management, business planning and computer systems validation experience to healthcare and pharmaceutical companies that are either facing or are under a Consent Decree.
Our diverse experience, which also includes coaching, mentoring and team building in a GxP environment, has enabled our clients to successfully address regulatory challenges and operate in a more streamlined, compliant and cost-effective manner while increasing their own workforce’s intellectual knowledge.
More specifically, we provide the following services:
Implementing key performance indicators for compliance to focus the expenditure of funds for continuous improvement (cost of quality)
Providing independent auditing capability to ensure Quality Management systems that provide a high degree of assurance of data management
Creating and implementing Disaster Recovery and business continuity processes
Automation and cloud base application support to reduce operating cost variability while increasing existing manufacturing capability
Our experienced subject matter experts provide:
Consent Decree Expertise —We have Consent Decree expertise both as a member of remediation teams and as a member of the third party. Our associates also have PAI (Pre‐Approval Inspection) expertise.
Comprehensive Computer System Validation Technology—We have the technology to support validation systems for automation/manufacturing, laboratories, packaging, and quality assurance.
Full Operational Expertise —We have consultants with expertise in Tech Transfer under Consent Decree environments, including the following:
•NDA Submission Expertise
•Computer System Validation
Pharmaceutical Or Manufacturing Experience—Our consultants’ experience allows competitive offerings and use of current technology. Additionally, our Life Sciences Director holds a Master of Science (equivalent) in Nuclear Engineering from the US Navy Nuclear Power School. This experience sets us apart from our competitors.