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CONSULTING

The New Environment for Product Development

The dynamic environment in which product developers operate is rapidly evolving. Ever-changing regulations and policies now, more than ever before, require the strategic application of science to meet shifting stakeholder needs.

Tougher Requirements

The methods used by regulatory agencies to evaluate potential human health risks are changing. These new methods often require the development of specialized scientific data, and/or critical analysis of existing data, to provide credible assessments.

Introducing Science Strategies Consulting Group

Science Strategies Consulting Group — the consulting practice of SafetyCall™ International — augments existing company resources to help satisfy these new and evolving requirements.

Uniquely Qualified

Science Strategies Consulting Group is uniquely qualified to provide integrated consulting services in many areas of science and regulatory affairs. These services directly apply to important statutory requirements (such as FIFRA, TSCA, Proposition 65, and EU) and related activities. Science Strategies Consulting Group has demonstrated leadership in safety assessment for product development efforts as well as for post-marketing safety surveillance for consumer products.

Science Strategies Consulting Group Advantages

Science Strategies offers distinct advantages over other consulting practices. These advantages include:

• Applied clinical expertise

• Quick response

• Cost-effective flexibility

• Broadbased staff with extensive experience in industry

• Network of scientific and regulatory affiliates in complimentary areas (analytical chemistry, biostatistics, epidemiology, pathology, etc.)

• Handling your adverse events results in more effective professional consulting

Core Consulting Services

Regulatory

• Labeling and packaging guidance

• Registration assistance (through affiliates)

• Addressing of regulatory concerns with science – see below

Hazard Identification and Dose Response Assessment

• Extensive literature searching and critical evaluation of data

• Development of toxicological profiles

• Mammalian toxicology and clinical safety studies (design, monitoring, data analysis, and interpretation)

Exposure Assessment

• Design, placement, monitoring, and evaluation of human exposure monitoring studies

• Mathematical modeling of exposures – simple point estimates through probabilistic assessments

Risk Assessment

• Integration of Hazard Identification/Dose Response Assessment and Exposure Assessment

• Recommendation for risk management options 

Medical

• Critical evaluation of clinical cases

• Evidence-based causation assessment

Product Safety

• Labeling advice (first aid, cautionary, and hazard statements)

• MSDS review

• Failure analysis

• Packaging assessment

• Formulation reviews