QUALITY

COMPLIANCE

FLEXIBILITY

CONSULTING SERVICES FOR LIFE SCIENCE ORGANIZATIONS

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WHY HELLERSTEIN CONSULTING?


We are by no means the only company offering Quality and regulatory compliance consulting services. However, our focus on small biotech firms and institutional core labs offers several advantages:


Our approach is flexible.


We realize that big-company solutions often do not work well in smaller organizations. Long, drawn-out processes may be entirely appropriate for a global pharmaceutical company, but such processes will drastically reduce the efficiency of a small firm. We recognize the need to remain nimble, and we adapt the compliance programs to the needs of the customer. We fit the solution to the customer, not vice-versa.


We do not compromise on quality.


We realize that quality is the bottom line. Efficiency, flexibility, and reasonable pricing have no value if the solution does not meet the client’s needs and the standards set by the regulatory authorities. Through our knowledge of regulations and best practices, careful attention to client requirements, and diligence, we will deliver solutions that meet or exceed clients’ expectations.


Our rates are reasonable.


Addressing the Quality and compliance needs of a biotech startup does not always require the experience gained in 30 years in pharma or at FDA.  We have the experience and know-how required to move a product or service through the early stages of development and to build a solid foundation for expansion. We do not have decades of experience with late-stage pharmaceutical development , Phase IV trials, billion-dollar drugs, and so on. For a biotech startup, such experience in a consultant is essentially unused capacity, since many of the issues relevant to marketed drugs do not apply. We offer our clients the benefits of our relevant experience without the costs of extensive but largely unneeded expertise in late-stage development.


Through partnerships, we provide complete solutions.


Through our network of partners, we can provide clients with complete solutions from early discovery through commercialization, from laboratory science to advanced manufacturing.  If we can’t help you, we know someone who can.

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