WE ARE A COMPANY OF CONSULTANTS WITH EXTENSIVE KNOWLEDGE AND EXPERIENCE IN:

• International manufacturing site selection and analysis
• Technology transfer under cGMP to corporate partners and contract suppliers
• Strategic pharmaceutical operations management consulting
• Organizational excellence, team building and operational analysis for entrepreneurial manufacturing organizations
• Development and scale-up of robust and compliant manufacturing processes
• Definition of and set-up of cGMP-compliant systems for manufacturing control, quality assurance and process, equipment and utility validation
• Design, construction and validation of pharmaceutical manufacturing facilities, including both production and materials management automation

WE HAVE PARTICULAR EXPERTISE WORKING ON:

• Contract and corporate partner manufacturing management
• Budget projection and financial control of internal and external manufacturing
• Interim manufacturing and operations management
• Pharmaceutical manufacturing facility design and start-up
• cGMP manufacturing layouts, configurations and equipment
• Outsourcing and technology transfer of cGMP-compliant production
• Scale-up and compliant technology transfer of biopharmaceutical and pharmaceutical products
• Recovery and purification of biotherapeutics and vaccines
• Preparation of CMC sections for regulatory filings and the creation and implementation of cGMP compliance systems

WE SPECIALIZE IN THE DEVELOPMENT OF:

• Cost-effective and reproducible manufacturing processes
• Process validation strategies
• Organizational and system requirements to support manufacturing and operations
• Efficient compliance systems and cGMP audits