Manufacturing & packaging in the pharma & biotech field
Production process engineers from the pharma and biotech fields, who develop production processes for biological and chemical products, from the formulation stage, conducting preclinical and clinical trials, scaling-up and assimilation of manufacturing and packaging technologies rely on their work on quality principles, production conditions and conditions. .
In-depth knowledge of the product, manufacturing processes, patients, and quality, while understanding the regulatory requirements and risk analysis, is essential to integrate the product into the World Health Authorities as well as supporting a proper and rapid development process, with no delays that will form a solid foundation throughout the life of the product. Life sciences industries, characterized by a competitive environment and public pressure over the last decade, have been subject to increasing price reductions and demand for efficient, high-quality and safe products.
Manufacturing & packaging consulting services in the pharma & biotech field
Manufacturing and packaging process troubleshooting
Manufacturing and packaging process engineering
Risk assessment and risk analysis
Product shelf life determination
Process & equipment GMP and sanitary design
Gowning and clean rooms training
Annual GMP Training
Manufacturing processes set-up and optimization
Audit, gap analysis and training towares regulatory inspection
New manufacturing technology consulting
Writing URS and design review
Validation for manufacturing and cleaning processes
Manufacturing and packaging processes improvements
Validation training
Operation, cleaning, and maintenance procedures writing
GMP Consulting
New facilities conceptual design
Manufacturing process controls implementation
Other pharma & biotech services