QUALITY

COMPLIANCE

FLEXIBILITY

CONSULTING SERVICES FOR LIFE SCIENCE ORGANIZATIONS

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AS A LIFE SCIENCE ENTREPRENEUR, YOU ALREADY HAVE ENOUGH ON YOUR HANDS.


You may be advancing your lead drug candidate, putting the finishing touches on your new diagnostic kit, or rolling out a service offering for the research labs at your university. Regardless of the nature of your products or services, you are constantly dealing with new challenges.  Our consulting services allow you to focus on the science and the business opportunities. Regulatory compliance, documentation, and Quality Systems are all critical to the advancement of your technology, but they don’t need to slow down progress on your critical path.  Let us show you how our expertise and flexible approach can accelerate your growth.

WHY US?


Our focus on small biotech firms and institutional core labs offers several advantages:


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CORE SERVICE OFFERINGS

We have extensive experience in creation of new Quality Systems for life science laboratories. From document control to deviations to CAPA, we will design and create the systems needed to keep your lab operations in compliance as efficiently as possible.


A small biotech or core lab faces a conflict: lack of resources to employ full-time QA versus the regulatory requirement for a fully independent Quality unit. (This requirement prevents many other employees from putting on the QA “hat.”) We offer solutions.


A well-designed Quality strategy, implemented early and improved regularly, is key to the success of any biotech company or lab that operates under regulatory compliance. We can help you to design and implement your strategy for success.


NEW QUALITY SYSTEMS

CONTRACT QUALITY ASSURANCE

QUALITY STRATEGY SERVICES

WE CAN HELP YOU WITH A WIDE RANGE OF CHALLENGES.


In addition to our core services, we offer a variety of other consulting services in the following practice areas:














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