GxP Authority, Inc.

Pharmaceutical ManufacturingPennsylvania, United States11-50 Employees

GxP Authority, Inc. is a consultancy to the life sciences industry. Our clients include both emerging and established companies in the biotechnology, medical device, and pharmaceutical industries.

We have worked with dozens of life science companies to establish the infrastructure, regulatory compliance, and data governance practices needed to successfully advance data-driven product research and commercialization while optimizing resources (staff, time, and funding).

While life science companies compete in the same markets, we understand that each company has unique needs for research, clinical trial, regulatory review, and commercialization initiatives.  For this reason, we tailor our activities and deliverables to meet specific client needs based on the following core services:

Strategic Partnerships – thorough assessment of strategic partners to ensure consistent delivery of services, as well as active management to control the quality and cost of deliverables.

Technology Infrastructure – design, implementation, and formal qualification of on-premise and cloud-based infrastructure to ensure security, availability, performance, and business continuity.

Regulatory Compliance – design, implementation, training, and verification of by-design standard operating procedures for data security, privacy, and integrity (e.g., GDPR, HIPAA, 21 CFR Part 11, SOX).

Data Governance – design and implementation of the practices needed to ensure that only trusted data are used to make timely and ethical decisions for patients and investors (i.e., data that are accurate, complete, in context, and free from loss and corruption).

We work with life science companies in the Seattle, San Francisco, San Diego, Boston, New York, Philadelphia, and Washington DC areas. We are also available across the US, Canada, UK and EU.

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