Cursos de Especialización en Madrid

 

ÁREA DE INNOVACIÓN

La Patente y la Protección Intelectual

Gestión de Proyectos

 

ÁREA DE INDUSTRIA FARMACÉUTICA Y QUÍMICA FINA

Introducción a las Formas Farmacéuticas Sólidas

Formulación Cosmética

Normativa Regulatoria

Registros Farmacéuticos, el Expediente de Registro

Registros Farmacéuticos, la Información del Medicamento

Registros Farmacéuticos, Procedimientos de Registro

Precios y Financiación en el Registro Farmacéutico. Autorizaciones de Comercialización

Procedimientos Regulatorios Alimentarios

La Patente y la Protección Intelectual

Normas de Calidad en la Industria Farmacéutica

GMP's: Normas de Correcta Fabricación

GLP's: Buenas Prácticas de Laboratorio

GCP's: Buenas Prácticas Clínicas

Investigación de Nuevos Fármacos: Fase de Predesarrollo

Investigación de Nuevos Fármacos: Fase de Desarrollo Preclínico

Investigación de Nuevos Fármacos: Fase de Desarrollo Clínico

Investigación de Nuevos Fármacos: Fase de Desarrollo Industrial

Áreas y Servicios en la Industria Farmacéutica

El Mercado Farmacéutico: Actores

El Mercado Farmacéutico: Productos

Marketing Farmacéutico Específico

Química Orgánica Médica, Drug Discovery

Gestión de la Información y Comunicación en Ciencias de la Salud

 

ÁREA DE ANÁLISIS Y CONTROL

Introducción a la Cromatografía de Gases (GC) 30 h

Introducción a HPLC

Análisis Multielemental Mediante ICP-MS

Técnicas de Análisis Intrumental: UV-visible, FTIR, NIR, MS

Validaciones Analíticas

Validaciones Analíticas (teórico-práctico)

 

PHARMACEUTICAL

Pharmaceutical industry

InKemia IUCT group has been authorized by the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for medicinal drugs and Sanitary Products) as a pharmaceutical laboratory for drug production  (4155-E)

 

Control of pharmaceutical products

  • Assay
  • Impurities
  • Related substances
  • Residual solvents
  • Dissolution rate
  • Identification
  • Viscosity
  • Heavy metals
  • Humidity
  • Microbiological control
  • Endotoxins
  • Assay by microbiological method: antibiotic assessment, determination of B12 vitamin
  • Any other specified by the product

 

Water control

  • Purified water assays according to Pharmacopeia specifications
  • Potability

 

Surface and environmental control in production rooms

 

Isolation, purification and identification of products and impurities

 

DMF development

  • Analytical and experimental support
  • Structure and drafting support

Control of products in development

    • Preservative challenge testing
    • Ames test

Analytical methods

      • Design and set up of methods for physicochemical and microbiological analysis
      • Method validation according to ICH

Stability studies of pharmaceutical products

      • Protocol drafting for stability studies
      • Sample storage in climatic chambers according to ICH conditions
      • Analytical control
      • Report drafting of the stability study

For any inquiry regarding activities not listed do not hesitate to get in contact with us.

CHEMICAL

Fine chemical and chemical industries.

Structural elucidation studies of organic compounds

  • High field NMR
  • MS3 mass spectrometry
  • FTIR spectroscopy
  • Polarimetry
  • UV spectrophotometry

 

Synthesis

  • Analysis of chiral molecules
  • Separation of enantiomers
  • Determination of enantiomer excess
  • Ester selective synthesis
  • Purification of enantiomers

 

Intermediary and raw material control according to European Pharmacopeia or client’s requirements

  • Residual solvents
  • Impurities
  • Related substances
  • Assay
  • Identification
  • Viscosity
  • Water content
  • Heavy metals
  • Microbiological control
  • Any other specified by the product’s requirements

 

Isolation, purification and identification of products and impurities

  • Transfer of analytical scale methods to semi preparative scale
  • Scaffolds, synthesis intermediaries and final products purification
  • Structural elucidation

Analytical methods

  • Design and set up of methods for physicochemical and microbiological analysis
  • Method validation according to ICH

 

Surface and environmental control in production rooms

For any consult regarding activities not listed do not doubt to contact us.

BIOTECHNOLOGICAL

Industrial Biotechnology

  • Development of non-pathogen genetically modified organisms
  • Research, isolation, characterization, and obtention of new microorganisms with biotechnological interest for their application in the chemical synthesis and food industry sectors, among others. Therefore optimizing the classical synthesis routes and obtaining new products.
  • Obtention of novelty enzymes as industrial biocatalysts for the fine chemistry sectors and related activities.

 

Techniques of specialization

  • Cloning of eukaryotic and prokaryotic host cells
  • Cloning with a wide variety of vectors
  • Constitutive and induced expression of proteins in prokaryotes and yeasts.
    Primer design
  • Set-up for Bio-transformation reactions by means of microorganisms or purified fragments of microorganisms
  • Biosynthesis of antiviral and anti-cancer APIs
  • Biosynthesis of monomers and K3 vitamin
  • Product and metabolite purification
  • Product or metabolite identification. Creation of fusion proteins.
  • Qualitative and quantitative determination of DNA, RNA and proteins
  • Ames test

 

Biosynthesis (Biocatalysis or Fermentations)

  • High yield biotechnological synthesis of APIs. More efficient and less contaminating processes. Higher yields and less production of impurities
  • Substitution of chemical process for biotechnological ones. Alternative routes not protected by intellectual properties. High selectivity. Minimization of reaction stages.
  • Design and optimization of biocatalysts
  • Design of biocatalytic processes
  • Scale-up studies of biotechnological processes

For any inquiry regarding activities not listed do not hesitate to contact us.

COSMETIC

Cosmetic Industry

InKemia IUCT group has been authorized by the Dirección General de Farmacia y Productos Sanitarios (General Management of Pharmacy and Sanitary Products) for the control of cosmetic products (8611-LC). 

 

Control of physicochemical and microbiological parameters:

  • Assay
  • Impurities
  • Residual solvents
  • Viscosity
  • Heavy metals
  • Water content
  • Microbiological control
  • Any parameter specified by the product

 

Control of products in development

  • Preservative challenge testing
  • Ames test

Analytical methods

  • Design and set up of methods for physicochemical and microbiological analysis
  • Method validation according to ICH

Stability studies in cosmetic products

  • Protocol drafting for stability studies
  • Sample storage in climatic chambers according to ICH conditions
  • Analytical control
  • Report drafting of the stability study

For any inquiry regarding activities not listed do not hesitate to contact us.

FOOD AND RELATED LABORATORY

 

FOOD ANALYSIS

At INKEMIA Laboratories we offer a full set of food lab services. We perform analyzes on a wide range of parameters in all types of products.

Main food analyses include:

• Microbiological analysis: Compliance with regulatory standards and legislation from different competent bodies. Characterization of micro flora and pathogens in ready to eat products, packaged food and intermediates.

• Physicochemical analysis: nutritional analysis, nutritional facts checking and analysis, food labeling assessment to follow European and international legislation, etc.
• Protocols in hygiene, safety and quality: analysis of food samples, hygiene in surfaces and food handlers, etc.

WATER

At INKEMIAwe perform all kind of analysis on waste and drinking water for government agencies, businesses and individuals.

Main water analyses include:

• Analysis of drinking water from wells and cisterns.
• Tap water: Quality control of tap water from food manufacturers (water used in the process to elaborate food products)
• Complete analysis by applicable law and regulation
• Pools and Spas: regular monitoring to ensure proper maintenance and safety of sports and leisure facilities
• Legionella control analysis
• Wastewater: Analysis according to legislation and regulation.

R & D

At INKEMIA Laboratories we are committed to help the food industry to meet current and future needs. To that extend with develop research for new and better techniques of analysis. And, equally important, we also help companies to improve their current analysis and processes.

Following these principles, ASLAB Laboratories has enhanced technically food products (following food operators’ needs) in areas such as: longer shelf-life, better nutritional profile and less or better additives. In order to achieve our customer goals in these areas we work side by side with the R&D and quality departments of food manufacturers.

The key areas of work supporting R&A include:

• Shelf-life studies – Validation of product Shelf-Life
• Challenge Test
• Study of additives vs. product Shelf-life
• Design / develop new products based on customer specifications
• Feasibility study of different kind of packaging

CONSULTING

At INKEMIA Laboratories we provide a complete consulting service to its customers to achieve the quality objectives that they need to compete effectively. We provide consulting services focused on implementation of international or national standards in the fields of food, quality and environment.

The main fields in consulting services include:

• Support plans of HACCP according to EC legislation. Design and implementation of proper hygienic practices in your facility.
• HACCP (Hazard analysis and critical control points): design, implementation and maintenance in all food industry sectors.
• Implementation of international food standards IFS / BRC / ISO 22.000
• Legislative advice to comply with legal compliance regulations and voluntary compliance.
• Advice on labeling (EC, US)
• Conducting internal audits / external
• Implementation of quality and environmental standards: ISO 9001 and ISO 14000.

EDUCATION

At INKEMIA we also perform training courses addressing the needs of the food industry and catering.

The main education courses we provide include:

• Education in GMP to Food handlers and supervisors (Good manufacturing practice): e-learning and on site
With our courses, food handlers and supervisors receive appropriate training in proper food handling techniques and food-protection principles. They also receive education on the dangers of poor personal hygiene and sanitary practices.
Training programs are periodically reviewed and up dated to ensure food handlers remain aware of all up-to-date procedures necessary to maintain safety and prevent adulteration of food.
• Customized courses on different subjects: food processing, handling, hygiene, allergens etc.
• Quality Courses: custom implementation of HACCP, IFS, BRC, etc.

See iuct.com for more courses

ACCREDITATIONS

BACK OFFICE

For any inquiry regarding activities not listed do not doubt to contact us.

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Contact

  •   info@inkemia.com
  •  +34 93 579 34 32
  •  +34 93 570 57 45
  •  C\ Àlvarez de Castro, 63, 08100
    Mollet del Vallès (Barcelona)