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About the Company
Waldman Biomedical Consultancy, Inc., an international advisory group, was founded by Dr. Alan A. Waldman in 1988. Consultancy is offered on every aspect of bringing a product from strategic definition through production, processing and testing, to regulatory approval, licensure and distribution.
The Consultancy provides counsel and support in:
• evaluation of technologies and markets
• strategic planning and obtaining funding
• optimization of organization and operations
• project review and coordination
• development, scale-up and documentation of production schema
• all aspects of outsourcing
• compliance with QSR, GMP and ISO standards
• qualification and validation of facilities and operations
• creation of regulatory strategies
• all aspects of product and plant registration, including
• creation and conduct of clinical trials
• creation and filings of all necessary documents
• preparation for FDA inspections
• interactions, at every level, with regulatory agencies, including responses to Warning Letters.
Our clients are manufacturers of devices, therapeutics, drugs, and biologics, including assay and diagnostic systems of all kinds. Clients include companies in the United States, Germany, England, France, Sweden, Switzerland, Israel, Japan and China.
Assignments, handled by selected experts, have included: product development, facility and computer system qualification and validation, training of staff in GLP and GMP, creation and institution of complete standard operating procedures, design and documentation of Q.C., Q.A. and compliance operations and related protocols, inspections, creation and conduct of clinical trials, management of all aspects of registration of products, and dealing with Warning Letters.
To share what we have learned from our previous work, see below or go to www.waldmanpublications.com
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