Specific Services

Our consultation service includes:

• Authority requirements for pilot and commercial scale production
• Manufacturing process analysis (e.g. consistency, stability and regulations)
• Manufacturing cost analysis, identification of cost driver and benchmarking
• Manufacturing process optimisation and trouble shooting
• Assessment of personnel education, capacity analysis and proposal for day-to-day business (e.g. shift)
• Advice on single and multi product facility concepts
• Strategy and advice on FDA / EMEA applications, incl. direct contact with the authorities
• Preparation for FDA / EMEA product inspections
• Advice on production expansion strategies, best scale,  time and investment for:

		In-house or contract manufacturing decisions
		Activities and regulations of production transfers
		Development of organisational structures, suitable for GMP compliance and  inspections
		Due diligence of companies (e. g. contract   manufacturer, engineering / construction  companies)

SellWiss services support you in obtaining authority approvals, process efficiency improvements and provide for state-of-the-art project management.
This garantees a smooth transition from clone to market.

Specific case-by-case consultation is the key to your success - we provide it.