Pharmaceutical Development and Medical Devices

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

	Lead compound selection and the identification and evaluation of external capabilities to initiate nonclinical development programs
	Protocol development, study placement and monitoring, report writing and reviews of nonclinical programs
	Pharmacokinetic and pharmacodynamic study planning, placement, monitoring, and analysis
	Preparation of nonclinical documents and IND preparation, review and meeting preparation with the FDA
	Preparation and review of CTD/NDA and BLA
	Preparation of Investigator Brochures, early stage clinical protocols and clinical trial reports
	Develop regulatory strategies for nonclinical and early stage clinical drug development
	Assist clients in developing strategies and responding to regulatory clinical hold and anticipated regulatory enforcements
	Development of nonclinical strategies and designed mechanistic studies to explain potential human risks associated with unexpected toxicity
	Development of risk assessments and qualifications for impurities and degradants found in drug substances and drug products

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.

	Prepared safety and risk assessments for ingredients used in foods
	Prepared safety and risk assessments of cosmetic ingredients and home care products and ingredients
	Prepared expert reports for submissions to regulatory agencies (FDA, EPA) and for non-governmental groups such as the Cosmetic Ingredient Review (CIR) Panel
	Prepared food additive petitions, Food Contact Notification and GRAS self-determinations