Pharmaceutical Development and Medical Devices

We have assisted clients with a variety of pharmaceutical and medical device needs including:

	Lead product selection and the identification and evaluation of external capabilities to initiate preclinical and clinical development programs.
	Protocol development, study placement and monitoring, report writing and reviews
	IND preparation, review and filing with the FDA
	Preparation of Investigator Brochures, clinical protocols and clinical trial reports and placement and management of Phase I studies
	Case record form (CRFs) design and preparation for single and multi-site clinical studies
	Pharmacokinetic and pharmacodynamic study planning, placement, monitoring, and analysis

Consumer Products

We have specialized experience with a variety of consumer products including home and personal care products, cosmetics and fragrances and food additives and ingredients. We have prepared:

	Safety assessments for ingredients used in foods, cosmetics and home care products
	Risk assessments of cosmetic ingredients and food additives and ingredients
	Expert reports for submissions to regulatory agencies and for non-governmental groups such as the Cosmetic Ingredient Review (CIR) Panel
	Food additive petitions, Food Contact Notifications and GRAS self-determinations