Christopher Rush, MBA

Provides scientific, regulatory, and quality assurance support to global pharmaceutical, medical device and biotech organizations by offering sound compliance advice through a network of experienced industry and Health Authority individuals. Interacts with client QA departments to develop customized solutions including strategy, on-site audit schedule and compliance initiatives.

Providing value and insight to the GCP Committee as a contributing member.

The Orange Report is a quality focused community connecting suppliers and subscribers in the life sciences industry.

ATMOSAir was founded based on a two-fold mission to fulfill the needs of both aircraft owners and non-owners seeking efficient private air travel. For light jet owners: We reduce the cost and complexity of ownership by utilizing owners’ underutilized jets in a professionally managed, FAA-Approved, highly-specialized commercial aviation operation. For private air travelers: We encourage and support the growing demand for efficient, short-haul private jet air travel around the State of Texas and surrounding regions. ATMOSAir is guided by the wisdom gathered through nearly three decades of experience in private aviation, and we are driven by the passion to bring efficient private air travel to our community in only the latest generation of jet aircraft.

PCSglobal is a pharmaceutical, biotechnology and medical device industries consulting company. We provide a wide range of risk-reduction services at a cost-effective price, including customized and unique pharmacovigilance services and solutions, training/education, auditing and product litigation scientific analyses. We help companies to address urgent and routine issues by quickly mobilizing teams of trusted, highly qualified professional industry veterans with integrity, special skills and relevant knowledge who possess decades of collective experience and the expertise to accomplish your goals. Our scope is extensive, including North America, South America, Asia-Pacific, Japan and Europe. We maintain low overhead costs so that we can price our services at reasonable levels. Let us know how we can help you. Services include Drug & Medical Device Litigation Scientific Analyses Risk Management Safety Signaling Dictionary Management Adverse Event Reporting Programs Auditing, SOP creation, Compliance, Inspection Readiness

MonitorCRO USA specializes in providing biopharmaceutical companies with bioequivalence, pharmacokinetics and early phase (1/2a) studies. Additionally we offer adjunct services for early clinical trial and pharmacokinetic studies including pharmacovigilance services and reporting, project management, statistical reports (in-house and outsourced) and study reports. In coordination with our supplier company, MonitorCRO, we are able to provide timely and cost-effective biopharmaceutical services for all of your needs. Our services include complete risk oversight by our team of FDA experienced auditors. Our studies adhere to the required FDA Good Clinical Practice (GCP), Good Laboratories Practice (GLP) guidelines and all applicable International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) regulations. Rest assured that when you select MonitorCRO USA you are getting the highest possible quality along with in-house medical expertise. Our supplier company, MonitorCRO, has completed over 100 bioequivalence (BE) and bioavailability (BA) studies throughout Europe since 2000. Why pay more for your studies when you can get quality work at a lower cost?

Developed, supported and executed Compliance strategies and initiatives across PPD and represented Global Quality and Compliance (GQ&C) with facilitation of client audits and regulatory authority inspections and tracked client audits and findings, and analyzes trends to provide input into various GQ&C initiatives. Oversaw compliance management processes and materials, and provides any other support or knowledge necessary to advance the vision of the GQ&C department. Supervised direct reports across three regions (North America, Asia Pacific and Europe-Africa).

Responsible and accountable for delivering CLIA waived status on Axis-Shield products in the United States including but not limited to; crafting appropriate U.S. regulatory & approval strategy, identifying with U.S. Commercial Team key clinical trial sites, managing PI’s/Physicians and Patient Enrollment for clinical trials and working with FDA to gain waived status approvals. Ensured Axis-Shield activities related to US products are in compliance with regulations applicable to the IVD industry. Implemented a Quality System at our US distribution center, while serving as the Quality Management Representative and participated as an active member of the US Senior Management Team offering RA/QA support in a strategic and leadership role.

Conducted Clinical Quality Assurance audits, including routine and for cause audits that include all audit activities consisting of preparation and conduct of the audit, presentation of findings to the auditees, report writing, evaluation of the follow-up action plan in order to assess compliance to Novartis established practices/standards and established regulations. Interacted with Health Authorities to fulfill inspection requests and coordinates inspection activities, including investigator, sponsor-monitor/CRO inspections both locally and abroad. Developed and provided compliance training to CQA and clinical development staff and in all aspects of quality assurance, GCP compliance regarding the compliance/quality issues involving and safety reporting. Audit types include Clinical Investigator Sites, Systems, Third Parties (CRO/Central Laboratories/Phase I facilities, IRBs), Country Pharma Organizations – Sponsor/Monitor