Development & Manufacturing Consulting and outsourcing services
		Chemical & Pharmaceutical Development
			Drug development program assessment & planning
			Process development & scale-up
			Specifications development
			Analytical methods development & validation
			Stability assessment programs
			Clinical supplies
			Preparation & review of CMC Sections for IND & NDA submissions
		Clinical & Commercial Manufacturing
			Identification & evaluation of suppliers & contract manufacturers for active drug substance & finished drug products
			GMP compliance auditing
			Technology transfer assistance
			Raw materials vendor certification programs
			Supply agreement negotiation
			Technical liaison with contract manufacturers
		Quality Assurance / GMP Compliance
			Document control systems assessment
			Document preparation & review -- - Development reports - SOPís & protocols
			Validation master planning ñ facilities, process, cleaning validation
			Assistance in GMP facility design planning
		Additional Resources: PDA ñ Parenteral Drug Association ñ courses, publications, great discussion group Pharmaceutical Online news, marketplace, sources for materials, equipment, contractors FDA CDER : guidelines, approvals FDA CBER home page Pharmweb ñ resource guide - meetings, yellow pages, newsgroups DIA ñ Drug Information Association ñ all aspects of drug development, meetings, publications, strong on clinical/regulatory & international issues American Chemical Society guide to chemistry resources Chemcyclopedia -- online buyers guide
		P.O. Box 1707 Tel: 425-235-7087 Issaquah, Washington 98027 Fax: 425-235-1141 email bdeBPR@earthlink.net

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