SECTIONS

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MEDICAL DEVICES dECEMBER 2018

SECTION 1



      R&D in medicinal / medical devices / cosmetic products / food supplements / bases for galenical preparations

  • Biological safety tests
  • Claim support tests, for example:

depth of transdermal crossing of substances,

trans epidermal water loss (TEWL),

antioxidant action,

skin elasticity,

moisturizing action,

wrinkles depth.

  • HET CAM tests
  • Nanotechnology products development
  • Freeze Dried pharma products development and scaling up
  • Novel medicinal molecules synthesis
  • Synthesis of Impurities of commercial medicinal molecules
  • Stability studies
  • NMR, DSC, XRD, SEM, TEM studies
  • Supervision of industrial productions
  • Development/maintenance of Quality Technical Agreements
    • with finished product manufacturers
    • with material suppliers (API, excipients, etc)
    • with contract analytical labs
    • with distributors

in compliance with regulatory requirements.

  • Editing of: Drugs CTD, Natural Drugs CTD, Medical Devices Technical Dossier, Cosmetic Products Information File, Food Supplements Technical Dossier
  • Scientific reports for Medical Devices
  • Risk / Safety Assessment Reports for cosmetics and medical devices


  


























SECTION 2



      • R&D in spirits, essential oils / olive oil products / fragrances.
      • Development and standardization of natural raw materials
      • SDS (SAFETY DATA SHEET) and TDS (TECHNICAL DATA SHEET) of raw materials editing
      • Agricultural consulting for cultivation improvement

 

SECTION 3



IN COOPERATION WITH THE OFFICE OF ELECTROMECHANICAL STUDIES  'DIMITRIS TIMOLEON PANTELAKIS'
  • Industrial production lines cGMP / FDA Design
  • Plant cGMP / FDA design and construction (electromechanical design, structural design, industrial internal construction, air conditioning, water purification systems, waste disposal systems, BMS, active fire protection, lifting machinery, lightning protection)
  • Hospital units design
  • Pharmacy laboratory design














  • SITE MASTER FILE editing
  • OPERATION & PERFORMANCE QUALIFICATION PROTOCOLS & MEASUREMENTS for equipment & production lines.
  • Manufacturing lines design according to each kind of process and according to each process special needs.








IN COOPERATION WITH THE COMPANY
DARCO HELLAS S.A., www.darco.gr
TECHNICAL CONSULTING AND PROCESS DESIGN OF CLEANING AND SANITIZING OF ALL KIND OF INDUSTRIAL AREAS
AND PRODUCTION LINES EQUIPMENT, THROUGH THE USE OF SUPER-HEATED STEAM menikini.darco.gr

SECTION 4

        Training and Consulting in industrial research and routine issues, such as:

  • formulation development,
  • analytical development, 
  • production processes,
  • scale up processes,
  • stability studies.


FREEZE DRYING ANNEALING
     




SOLID FORMS FORMULATION
                                DEVELOPMENT



PARENTAL MEDICATION







PREDECTING PRIMARY DRYING
                                HOLDING TIME


DRUG STABILITY APIS &
                                FINISHED PRODUCTS








SECTION 5



  • Arrangement and development of experimental fields
  • Business plan development
  • Contract cultivation and connection with manufacturing industry
  • Creation and control of producers’ groups
  • Tailor made electronic applications for surveillance of incoming and out coming agricultural resources
  •  Creation of electronic trace ability systems at field level
  •  Geo technical support and cultivation consulting
  • Terrain analysis for pesticides / insecticides’ residues and analysis of organoleptic parameters
  • Agriculturists’ and producers’ training
  • Audits in production according to official rules and specifications