Morgenthaler Tox
Toxicology consulting services to Consumer Health and Consumer Product companies

Consulting
Morgenthaler Tox provides preclinical and toxicology expert advice during the full life-cycle of products from exploratory phase to launch of products and beyond.
The consultant, Phaik Morgenthaler has a Ph.D in Toxicology from MIT, USA in 1984. Phaik has over 28 years experience in preclinical, toxicology and risk management in the Consumer Health and Food Industries. She has worked at the Nestle Research Center, Novartis Consumer Health and Bayer Consumer Health. She also has over 10 years experience in academic research. During that time, broad experience and research in toxicology, new product development in OTC medicines (including switches), medical devices, cosmetics, and other consumer products was acquired.
The extensive experience resulted in comprehensive knowledge and fundamental understanding of the needs of new product development and maintenance of products. Putting the knowledge into practical practice is one of the expertise provided by Morgenthaler Tox.

OTC Medicines
Develop strategy to address toxicological requirements for reformulation of products, changes in packaging, switches
Prepare expert report to address potential toxicological issues:
- Calculation and safety assessment of process impurities, residual solvents, degradants, and excipients e.g. flavors
- Calculation and safety assessment of out of specifications (OOS) in impurities and degradation products
Medical devices
Comprehensive knowledge of Biological evaluation of medical devices according to ISO 10993-1
- to develop strategy for biocompatibility testing
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- to address needs of Extractables and Leachables testing and risk assessment
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- to address requirements for biocompatability and risk assessment of packaging
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- to address requirements and strategy for changes to raw material, supplier or manufacturer
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- Preparation of Biological evaluation and Toxicological assessment
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- Interaction with Notifying Bodie

Due diligence for in licensing of products
Review of preclinical and toxicity information to identify potential red flags and develop strategy for mitigation