QUALITY

COMPLIANCE

FLEXIBILITY

CONSULTING SERVICES FOR LIFE SCIENCE ORGANIZATIONS

 Home

Core

Services

About

Us

Additional

Services

Why

Us?

Contact

OUR PRACTICE

Hellerstein Consulting is dedicated to providing flexible, cost-effective consulting services to clients in the life science field. We come from the world of startups and small biotech firms. We understand your challenges and dilemmas because we’ve seen them before.


A new biotech firm or an institutional lab seeking to offer GxP-compliant services faces a number of challenges in the area of Quality. In order to advance a product or service to market, the company or lab must implement and maintain compliant Quality Systems. The standard options are less than ideal:



We faced this same difficulty and spent years developing our own abilities to handle Quality Systems for small organizations. As consultants, we now offer you the benefit of our experience, at rates that will not break your budget.

MEET OUR TEAM

MIKE HELLERSTEIN, PRESIDENT


Mr. Hellerstein specializes in regulatory (GxP) Quality, manufacturing Quality, validation, process improvements, and operations.  He has extensive experience in Quality Assurance, Quality Control, analytical method validation, outsourcing, biologics research and development, and laboratory management.  Mr. Hellerstein's broad experience allows him to support clients with a wide variety of services including GxP-compliant documentation, audits, investigations, validation, process improvement, and planning and organization of laboratory operations.  Prior to founding Hellerstein Consulting, LLC, Mr. Hellerstein served as Director of Quality Control at GeoVax, Inc., where he handled a broad range of duties in QC, QA, operations, outsourcing, management, and research.  Previously, Mr. Hellerstein co-founded Blue Sky Biotech, Inc. (a contract research firm) and held positions at Pfizer, Inc. and Cell Signaling Technology, Inc.


View Mike’s LinkedIn profile


HEATHER BARA, PH.D., RAC, VICE PRESIDENT


Dr. Bara combines a brilliant record of laboratory research with a comprehensive knowledge of regulatory requirements to offer clients expert advice, research, and document creation in the fields of regulatory affairs, biologics, and biomedical engineering. Dr. Bara earned her Ph.D. from the joint Emory/Georgia Tech Biomedical Engineering program. During her graduate work, she developed a tissue engineered pancreas from its molecular biology beginning to in vivo evaluation. Recently, Dr. Bara has focused on regulatory affairs, and she currently handles projects ranging from review of clients' CMC text to the writing and assembly of entire FDA filings. Dr. Bara's deep technical knowledge and strong understanding of the regulatory landscape allow her to provide clients with regulatory strategies and documents that are logically constructed, clearly written, and solidly grounded in scientific method.


LESLIE MADDOCK, M.A., TECHNICAL WRITER


Ms. Maddock has more than 20 years of experience in technical writing in industries including biotechnology, medical diagnostics, and software. She has worked for firms including EMC Corporation, Bayer HealthCare, Verizon, Lucent Technologies, GeoVax, Inc., and Mead Data Central, where she participated in the rollout of the revolutionary Lexis/Nexis software. Ms. Maddock specializes in creating simple, efficient, compliant instructions and documentation. She is highly skilled in transforming complicated, confusing text into clear, well-organized instructions and reference material.


BRIAN KENNEBREW, QUALITY AND OPERATIONS CONSULTANT


Mr. Kennebrew is an expert in cGMP and GLP Quality with a unique understanding of manufacturing Quality.  He is a full-time Quality Assurance Associate at Dendreon, Inc.  Mr. Kennebrew is enabled to consult on a part-time basis because of the shift schedule at the biologics manufacturing plant.  At Dendreon, Inc., Mr. Kennebrew is responsible for preparation of batch records, review and approval of GMP documentation, investigation and closure of deviations, and training of personnel.  For Hellerstein Consulting, LLC, he brings considerable value through skilled document review, audit preparation, and operational Quality.

Home

Contact

About

Us

Core Services

Additional

Services

Why

Us?

Partners