Analytical Development and expertise

Analytical Development and expertise
Product Description

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment) and Extractable Leachable (EL) capabilities.
Equipment:
Centrifugation for heat-sensitive productsSurface area and pore size analyzer (BET)Friability, disintegration, viscometry, etc.Brookfield viscometerUV-Visible and IR/NIR spectrophotometers (Perkin Elmer)Karl Fisher titrator (Mettler)PotentiometryLaser diffraction particle size analysis (Malvern)Total organic carbon (TOC) analyzerHPLC/UHPLC (water/agilent) with PDA multiwavelength detector, UV detector, refractometerGas chromatography (GC) detectors: FID & TCDUV On-/Offline automated dissolution testing (SOTAX)Automatic Mortar Grinder, Stability cambers, Vitek®, BET Surface Area and Pore Size Analyzer.

Read more Show less

Skyepharma Production S.A.S

  • FR
  • 2017
    On CPHI since
View company profile
Categories
more categories Show less

Skyepharma Production S.A.S

  • FR
  • 2017
    On CPHI since
View company profile

More Products from Skyepharma Production S.A.S (15)

  • Microfluidizer technology

    Product Microfluidizer technology

    By using microfluidization technology process, Skyepharma provides solution to increase bioavailabity of poorly soluble APIs (micro and nanoparticule). It is also an interesting technology for micro and nano emulsion manufacturing.
  • Regulatory services

    Product Regulatory services

    NDA/ANDA MAA-CTD writing Regulatory support
  • Worldwide production and supply (US, EU, Russia, Asia/Pacific, EMEA, Latam)

    Product Worldwide production and supply (US, EU, Russia, Asia/Pacific, EMEA, Latam)

    Certifications : FDA, Europe, ANVISA, Korean FDA etc.
  • Early stage formulation Development & Process Design

    Product Early stage formulation Development & Process Design

    We have extensive experience in solving complex formulation challenges. Our experts can apply our extensive range of proprietary technologies for immediate (IR) and modified (MR) / sustained, slow (SR) / controlled (CR) / extended (XR, ER) / pulsed / timed release as well as enteric and gastro reten...
  • Clinical trial material (CTM) manufacturing and release

    Product Clinical trial material (CTM) manufacturing and release

    We offer capabilities for manufacturing of small and large scale clinical trial material (CTM) as well as characterization and release from phase 1 to phase 3.
  • Manufacturing of complex and classic oral solid dosage forms

    Product Manufacturing of complex and classic oral solid dosage forms

    Manufacturing of classic and complex oral solid dosage forms:  single layer tablets, multi-layer tablets, tab-in-tab, tab-in-caps, hard gel capsules, powder & pellets.
  • Scale-up and Quality by Design (QbD) processes

    Product Scale-up and Quality by Design (QbD) processes

    Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing. We have powerfull compaction simulation tools ( STYL'One evolution) allowing to derisk and fasten scale-up steps. 
    Our capabilities :...
  • Packaging in Blister

    Product Packaging in Blister

    Primary packaging: Forming station for both PVCs and aluminium and all kind of feeder for tablets and capsules. Secondary packaging: Labelling, carton and casepacker.
  • Packaging in Bottle

    Product Packaging in Bottle

    Primary packaging : Plastic and glass bottles (round and square) loading station. Secondary packaging : sealing, labelling, carton and casepacker.
  • Packaging in Stick Pack

    Product Packaging in Stick Pack

    We can offer batch sizes from a few kilograms to several hundreds and the equipment is versatile in terms of material: powder, granules or pellets can be filled with PET / ALU / PE complex films up to 17 mm wide and up to 150 mm long. 
  • Serialization and Aggregation

    Product Serialization and Aggregation

    Bottle and blister lines fully serialized and aggregate.
  • Geoclock® Technology_Customisable chronotherapy

    Product Geoclock® Technology_Customisable chronotherapy

    Geoclock® allows for timed release of drugs that is independent of food or pH. Geoclock® is a validated oral drug delivery technology that can be used to release the drug from the tablet after a pre-determined lag-time that is independent of food or pH. Geoclock® can additionally be used for multi...
show all 15 other products

Skyepharma Production S.A.S resources (2)