Services offered by INGELYT include all aspects of the consultancy; from preliminary feasibility studies and search for business opportunities, to final manufacturing and continuous improvement of established pharmaceutical processes, since within our professionals we have experts in the pharmaceutical and similar sectors with the capacity and expertise to cover all the factors involved in pharmaceutical production, according to international standards: EU GMP, U.S. cGMP, ISO, PICs, CDC Guidelines, WHO Guidelines.
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0. Consultancy
Services offered by INGELYT include all aspects of the pharmaceutical business.
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1. Conceptual design
The Conceptual Design is based on the Business Plan guidelines wich define in detail which products to manufacture, and lots and volumes and pharmaceutical processes that will be used.
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2. Quality plans
From the early stages, the project has to be parallel to a quality system which ensures that all processes, equipment and facilities are designed, installed and functioning according to specifications.
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3. Technological support
Once the typology of the product is defined, the selection of the technology is critical for each phase of the productive process, as the correct selection of equipment, plant sizing and finally the correct definition of the processes.
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4. Production
Once the implementation of the quality system is completed and validated, and the Manufacturing Plant is authorized, industrial scale production starts, beginning with the commissioning of equipment, scaled and process validations.
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5. GMP training
During each project phase for all the activities involved it may be necessary to require GMP training.
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6. GMP consultancy
Ingelyt can perform in collaboration with the customer the whole GMP support for a new project.
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En INGELYT estamos a la vanguardia y somos pioneros en el sector en cumplir con el Diseño, Implantación y Mantenimiento de Planes y Programas de Prevención y Gestion de Riesgos Legales y Penales (CORPORATE COMPLIANCE)