GXP Advisory and Consulting

Consulting Solutions for every phase of the Product Lifecycle - From Discovery to Delivery™

Transitioning from R&D and pre-clinical to early-phase GxP clinical production, to scaling the process for later stage GxP clinical production, to commercial launch, routine operations, and continual improvement, manufacturers consistently face hurdles to achieve, mature, and maintain GxP compliance. After decades of research and development, manufacturers aspire to deliver their products to patients safely and as quickly as possible. But, for even the most established manufacturers, GxP compliance issues can impact production capacity, generate costly downtimes, and, in the most severe cases, impact their ability to supply products to patients.

That's where Azzur Group comes in.

No matter where you are in the product development lifecycle, we're here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.

With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance, and validation services specifically geared for the complexities of life science.

Our Services

Qualification & Validation

Computer System Validation

Quality Assurance & Regulatory Compliance

Service

Offerings

Operational Support Services

Comprehensive and proactive management of the processes, tools, and vendors from project initiation through closure.

Program Management
Project Management
Supplier Management
Process Improvement

Technology Transfer

Expertise and guidance to transfer knowledge between development and manufacturing or to new or upgraded facilities.

Azzur Cleanrooms On Demand™
Calibration and Equipment Rental
Commissioning, Qualification & Validation (CQV)
Laboratory Services & Environmental Monitoring
GxP and Compliance Advisory and Consulting

Facilities & Systems

Integration of critical systems, people, and processes to ensure facilities run efficiently and maintain an optimal state.

Controls & Automation
Critical Systems Assessment
Process Engineering
Reliability Engineering

Paramount to Azzur Group's knowledge and our clients' success our active participation and leadership among the nation's most established decision-making bodies: