Pharma and biotech manufacturing and packaging2020-08-12T09:56:34+00:00

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.

Quite a few companies are copying their manufacturing plants to countries characterized by cheap inputs and labor to reduce costs, maintain high levels of profitability and meet the growing competition challenges. Such a situation forces pharma and biotech companies to rethink the costs of development, production, operation and quality, to acquire and implement innovative technologies for streamlining processes characterized by a short return on investment, alongside the adoption of excellent process and operational methodologies such as Best lean, 5S, 6-Sigma and the like.

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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

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