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
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P.O. Box 1707 |
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Issaquah, Washington 98027 |
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