SafetyCall® Consulting Group
The consulting practice of SafetyCall International, PLLC augments existing company resources to help clients in the ever changing areas of product development, product safety, risk assessment and regulatory requirements.
Uniquely Qualified
SafetyCall 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) and related activities. SafetyCall Consulting Group has demonstrated leadership in safety assessment for product development efforts as well as for post-marketing safety surveillance for consumer products.
SafetyCall Consulting Group Advantages
SafetyCall offers distinct advantages over other consulting practices. These advantages include:
- Applied clinical expertise
- Quick response
- Cost-effective flexibility
- Broad based 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
Medical
- Critical evaluation of clinical cases
- Evidence-based causation assessment
Dietary Supplements/PMRA
- Nationally recognized experts in the field of supplement safety
Product Safety
- Labeling advice (first aid, cautionary, and hazard statements)
- MSDS review
- Failure analysis
- Packaging assessment
- Formulation reviews
Risk Assessment
- Integration of Hazard Identification/Dose Response Assessment and Exposure Assessment
- Recommendation for risk management options
Regulatory
- Labeling and packaging guidance
- Registration assistance (through affiliates)
- Addressing of regulatory concerns with science – see below
Identification and Dose Response
- 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
