Regulatory Support

Regulatory Support
Product Description

Cenexi provides wide range of services which includes regulatory support. The regulatory experts establish the market authorization files and the variation files with an experience of file writing for 114 countries in the world. Contact us for more information.

Cenexi

  • FR
  • 2015
    On CPHI since
Company types
Manufacturer/Innovator

Cenexi

  • FR
  • 2015
    On CPHI since
Company types
Manufacturer/Innovator

More Products from Cenexi (14)

  • Freeze dried (High potent)

    Product Freeze dried (High potent)

    Cenexi provides wide range of pharmaceutical products which includes oncology sterile vials and freeze dried. Characteristics: oncology products; vials from diameter 16 to 52 mm; high speed filling line in a class; 6 freeze driers for a global surface of 90 m². Equipment: washing machine libra hydra; steri...
  • Hard Gelatine Capsules

    Product Hard Gelatine Capsules

    Cenexi provides wide range of pharmaceutical products which includes hard gelatine capsules. Characteristics: all capsule formats available; powder and pellets filling; 100% mass control. Equipment: bertrams, diosna, moritz; glatt; imatic 120, imatic 150; sc500, scv 1600 precisa 120, precisa 16 (mass contr...
  • Hormonal Solid Forms

    Product Hormonal Solid Forms

    Cenexi provides wide range of pharmaceutical products which includes hormonal solid forms. Characteristics: dry granulation; wet granulation; tabletting; coating or sugar coating; hard gelatine capsule filling; packaging in blisters or tubes. Equipment: bohle, lodige, niro colette; ima; kilian; accelacota,...
  • Prefilled syringes

    Product Prefilled syringes

    Cenexi provides wide range of pharmaceutical products which includes oncology prefilled syringes. Characteristics: sterile filling with rabs; syringes from 1 to 50 ml; syringes with or without safety devices. Equipment: filling machine corima fsp05; ready for eris® safety device; labelling machine corima. ...
  • Process Development and optimisation

    Product Process Development and optimisation

    Cenexi provides wide range of services which includes process development and optimisation. It offers the following: sterile solutions; suspensions; emulsions; solid forms; freeze-dried forms; semi-solid forms. Contact us for more information.
  • Product Maintenance

    Product Product Maintenance

    Cenexi provides wide range of services which includes product maintenance. The experts are able to propose a strategy of product maintenance and of works in the following fields: analytics; formulation; process; packaging; regulatory. Contact us for more information.
  • Stabilities

    Product Stabilities

    Cenexi provides wide range of services which includes stabilities. It is able to realize pre-stability studies, regulatory or commercial stability studies according to the ICH conditions: 5°C; 25°C/60% RH; 30°C/65% RH; 30°C/75% RH; 40°C/75% RH; photostability. Contact us for more information.
  • Sterile Ampoules

    Product Sterile Ampoules

    Cenexi provides wide range of pharmaceutical products which includes ampoules. Characteristics:. It produces for the whole world and has one of the highest production capacities in europe; sap - controlled process; aseptic filling; type c ampoules, labelleed or silk-screen printed. Equipment: bosch filling...
  • Sterile vials

    Product Sterile vials

    Cenexi provides wide range of pharmaceutical products which includes sterile vials. Characteristics: vials from diameter 16 to 42 mm; high speed filling line in a class. Equipment: washing machine Vega 6; sterilisation tunnel Blue Galaxy; filling machine ima XTrema CML; sealing machine ima alu 400. Contact...
  • Syrups

    Product Syrups

    Cenexi provides wide range of pharmaceutical products which includes syrups. Characteristics: bottles from 50 to 125 ml; glass bottles; plastic bottles. Equipment: 2,500-l preparation tanks; 1,000-l preparation tanks; 400-l preparation tanks; farmomac f 640 filling and stoppering machine; cip-sip system. C...
  • Tablets

    Product Tablets

    Cenexi provides wide range of pharmaceutical products which includes tablets. Characteristics: direct compression; aqueous granulation; alcoholic granulation; tabletting; film-coating and sugar coating. Equipment: bertrams, diosna, moritz; glatt; fette, korsch; glatt coater, manesty. Contact us for more in...
  • Analytical Development

    Product Analytical Development

    Cenexi provides wide range of services which includes analytical development. It offers the following: study of active ingredients; development and validation of analytical methods; development and validation of analytical methods for cleaning validation; dissolution profiles and liberation profiles of the...