Ardena

About Ardena

We are Ardena, a reputable contract partner delivering drug development, manufacturing, logistics and (bio)analytical services to pharmaceutical customers globally.  In parallel, we work with you to compile your regulatory dossier and to fast track your product towards compliance.  Every day, we guide companies through the hurdles and challenges of drug development.  Our integrated service offering helps to streamline the drug's progress to clinic and beyond. Ardena is your one source contractor for the chemical and pharmaceutical development of your valued compounds.  In parallel, we provide you with full product analytical and bioanalytical support during development.  Our dossier centric approach makes a difference.  We work with you to compile your regulatory dossier in parallel with drug development, saving you time, identifying hurdles and fast tracking your product to compliance.  We are experts in writing and formatting supporting CMC documentation.

  • BE
  • 2015
    On CPhI since
  • 250 - 499
    Employees
Contract Service
Contact info

Products from Ardena

  • Analytical Development Service

    Product Analytical Development Service

    Ardena offers services under brand pharmavize which includes analytical development service. It includes api characterization, identification of degradant products and impurities (lc/ms), hplc/uplc/gc method development and optimization, dissolution method development, method validation and transfer activities, specification setting, quality control and release testing. Contact us for more information.
  • Bioanlysis Service

    Product Bioanlysis Service

    Ardena offers services under brand analytical biochemical laboratory which includes bioanlysis service. It is the main service offered to both preclinical and clinical development phase. It works for human pharmaceutical companies and contract research organization. Contact us for more information.
  • Chromatography Service

    Product Chromatography Service

    Ardena offers services under brand analytical biochemical laboratory which includes chromatography service. It has disposal of eight lc-ms/ms system(all sciex quadropole tandem mass spectrometry systems). Contact us for more information.
  • Clinical Supply Solutions Service

    Product Clinical Supply Solutions Service

    Ardena offers services under brand pharmavize which includes clinical supply solutions service. It has a promising drug molecule and it is preparing for preclinical or early phase clinical studie. Its business is to develop and manage the clinical supply materials, from design to delivery. It bring the api to clinics within a typical timeframe of 6 to 12 months. Contact us for more information.
  • Drug Discovery Service

    Product Drug Discovery Service

    Ardena offers services under brand analytical biochemical laboratory which includes drug discovery service. It is an integrated drug discovery company. Contact us for more information.
  • Drug Product Manufacturing Service

    Product Drug Product Manufacturing Service

    Ardena offers services under brand pharmavize which includes drug product manufacturing service. It can manufacture various dosage forms, including: solutions and (nano-)suspensions, powder and granule filled capsules, semi-solid and, liquid filled capsules, topical products, tablets, modified-release products, pellets and microspheres, spray-dried powders, powder blends for reconstitution, overencapsulated products. Contact us for more information.
  • Formulation & Process Development Service

    Product Formulation & Process Development Service

    Ardena offers services under brand pharmavize which includes formulation & process development service. It includes solubility screening, bio-availability enhancement, preformulation concept studies, api-excipient compatibility testing, early phase formulation development, formulation screening stability studies, development of drug delivery systems for controlled or in situ release, formulation optimization of marketed or existing drugs, process feasibility testing & upscaling, process validation, selection of suitable packaging materials. Contact us for more information.
  • Formulation Services

    Product Formulation Services

    Ardena offers services under brand crystallic which includes formulation services. It is the process in which different chemical substances, including the active pharmaceutical ingredient (api), are combined to produce a medicinal product. The api may be administered in a number of different formulations such as tablet, capsule, ointment, cream, injection, liquid, etc. It includes: preclinical formulations (stable suspensions, cyclodextrin complexation, amorphous dispersions, cosolvent solutions), phase i & ii formulations (powder in a bottle, powder mixtures for capsules, direct compressed tablets). Contact us for more information.
  • Immunochemistry Service

    Product Immunochemistry Service

    Ardena offers services under brand analytical biochemical laboratory which includes immunochemistry service. It has long track record of performing immunoassays for pk measurements, biomarkers and immunogenicity. Main techniques are: enzyme linked immuno assay(elisa), time resolved fluroscent immuno assay(trfia,autodelfia), radio immuno assay(ria), alphalisa, western blotting. Contact us for more information.
  • Preformulation Services

    Product Preformulation Services

    Ardena offers services under brand crystallic which includes preformulation services. Its activities typically start the candidate selection stage and continue into the clinical phase i, with optimization of the formulation and further characterization of the api taking place in, or after, phase ii clinical studies. It includes: molecular structure confirmation (elemental analysis, hplc method development, nmr spectroscopy, mass spectroscopy, ir/uv-visible spectroscopy.), molecular properties (pka, logp/logd, turbidimetric solubility, thermodynamic equilibrium solubility in water, organic solvents, buffers, formulation solvents, simulated body fluids), chemical stability in solution (temperature, ph, hydrolysis, oxidation, light-catalyzed degradation), excipient compatibilities), solid state properties (characterization of selected form (salt or neutral form) – dsc, tgms, hsm, xrpd, ftir/raman, stability stress studies temperature/ humidity, photostability – climate chambers, xrpd with hot-humidity stage, dvs, tgms, karl fisher, crystal habit microscopy, particle size and shape, surface area, dissolution behavior (intrinsic dissolution), common ion effect), powder properties (bulk and tap density, flow properties, odor & color, electrostatics, compression properties, compaction properties, milling, grinding & granulation (chemical physical stability)). Contact us for more information.
  • Regulatory & Quality Management Support Service

    Product Regulatory & Quality Management Support Service

    Ardena offers services under brand pharmavize which includes regulatory & quality management support service. It guarantees that its advice is in line with the latest cmc guidelines and directives. It deliver solutions and recommendations that allow it to develop an optimal cmc strategy. Its services will provide support with: data management, technical & regulatory writing (module 3): (impds and inds, marketing authorization dossiers, variations & updates), dossier publishing & submission (ectd). Contact us for more information.
  • Stability Studies Service

    Product Stability Studies Service

    Ardena offers services under brand pharmavize which includes stability studies service. Its ich stability storage facilities consist of over 100 m3 of walk-in stability rooms, fully secured with 24/7 electronic monitoring, alarm and backup power. It can execute: ich stability studies, accelerated studies (asap), photostability studies, in-use stability studies, ongoing stability studies. Contact us for more information.

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