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BioEthicA is an integrity driven consultancy organization utilizing former FDA & Industry Expertise, amplified by a culture of risk assessment, action and leadership.

BioEthicA's goals are simply to fully support its clients needs; to prevent or mitigate quality and compliance issues, to assist and strategize the quality management of the clientele's portfolio of drugs, biologics, supplements and combination devices.

The fastest growing segment of the pharmaceutical industry is the biologics, gene therapy and novel products, sector. Maneuvering through the evolving regulatory framework, originally written for classical chemical compounds can pose a challenge. Accurate interpretations of the Public Health Service Act, the US FD&C Act, its recent revisions and the promulgated Code of Federal Regulations can be difficult to navigate and apply. BioEthicA offers translation of the law and assistance with quality and compliance situations firms may face.
"Tara is an industry leader in quality and regulatory guidance. Her wide experience of commercial production, investigational drug development and multiproduct quality control gives her an exceptionally strong technical and regulatory knowledge. Tara has a very strong track record in building and maintaining quality systems that stand-up to internal and external regulatory scrutiny. Her engaging and bright personality elicits the ready collaboration and engagement of all staff - senior management to shop floor. As a result, Tara is highly valued and respected by her colleagues, stakeholders and clients alike."
-Scott Lorimer, VP Biologics Manufacturing and External Supply, Sanofi Biologics
Company Chairman, BioAtrium, Sanofi Biologics - Lonza Joint Venture, Switzerland
"Tara Greene supports leadership teams to excel through her powerful combination of industrial experience in complex biologics and the critical eye of a 6 year FDA field investigator with her passion to ensure compliance to deliver safe and efficacious therapeutics for patients. Tara has supported me to build robust quality management systems in both as a line management director and in a consulting role for the clinical and commercial supply of mAbs, proteins and viral vectors for gene therapy. I highly recommend Tara to support your needs to establish an effective, compliant QMS for your product development."
-Mark Bamforth, President and CEO, Brammer Bio
"Tara is an industry leader in quality and regulatory guidance. Her wide experience of commercial production, investigational drug development and multiproduct quality control gives her an exceptionally strong technical and regulatory knowledge. Tara has a very strong track record in building and maintaining quality systems that stand-up to internal and external regulatory scrutiny. Her engaging and bright personality elicits the ready collaboration and engagement of all staff - senior management to shop floor. As a result, Tara is highly valued and respected by her colleagues, stakeholders and clients alike."
-Scott Lorimer, VP Biologics Manufacturing and External Supply, Sanofi Biologics
Company Chairman, BioAtrium, Sanofi Biologics - Lonza Joint Venture, Switzerland
"I was Ms. Breckenridge-Greene’s supervisor and training officer at the FDA. I was extremely impressed with Tara’s knowledge of the pharmaceutical industry from day one. I found her very adaptable and her ability to grasp new concepts, particularly the Law, Regulations, and enforcement policies, was and are outstanding. Throughout her career with FDA she continuously impressed me and FDA Management with her knowledge, skills and abilities in all phases of the industry and FDA field work. She was promoted to a position as a District Drug Specialist, conducting the most complex and challenging inspections, both domestic and foreign. I remained Tara’s supervisor until I retired. Since retirement, Tara has retained my highest respect and admiration."
-Robert R. Wilson
U.S. FDA Supervisory CSO; Ret. 39 years
Executive Director, FDA Regulatory Guidance, LLC