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ANALYTICAL TESTING SERVICES

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Ardena’s drug product analytical testing technologies include: HPLC/UPLC-(H) with detector systems (RI, PDA,MS), A suite of state of the art dissolution testing like USP-1/USP-2 & USP-4 (Sotax, VanKell, Distek), particle size in dry and liquid state, etc.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

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BIOANALYTICAL TESTING SERVICES

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Ardena offers effective, accurate, comprehensive bioanalytical laboratory services for a wide range of pharmaceutical and biopharmaceutical products to fully define a candidate drug substance & drug product’s characteristics and its therapeutic effects.

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Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Overview

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CRYSTALLIZATION PROCESS DEVELOPMENT SERVICES

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Ardena, having process development capabilities, offers development of crystallization processes in parallel with manufacturing processes to optimise yield, flowability, particle size, bulk density, and facilitate downstream processing & formulation.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Crystallization Process

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PRE-FORMULATION SERVICES

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Ardena offers an extensive package of pre-formulation services to support the development programs from early candidate selection, through preclinical and into the clinic.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Overview

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API DEVELOPMENT SERVICES

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Ardena provides comprehensive drug substance development services by supporting the entire workflow required to make the drug substance available for clinical studies and market authorization.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Overview

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API PROCESS DEVELOPMENT CAPABILITIES

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Ardena's dedicated & experienced development team support process development, analytical development, process safety investigations & solid state research. Their process development labs house reactors from 0.5 L up to 20L, autoclaves from 10mL up to 5L.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

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SOLID STATE RESEARCH

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Ardena, with an extensive record in solid state research studies, provides services to obtain a complete range of solid forms of drug substance through a combination of high- & medium-throughput screening services, state-of-the-art analytical techniques.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Solid State Characterization

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PROCESS SAFETY INVESTIGATION SERVICES

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Ardena has world-class drug substance process development capabilities including process safety investigation, route scouting, crystallisation process development, process scale-up, etc.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Safety Assessment

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CDMO FOR PEPTIDE DEVELOPMENT

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Ardena is a CDMO offering custom peptide synthesis and peptide development services. It offers custom peptide development, peptide manufacturing, peptide drug development along with the production of complex peptide APIs.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Protein / Peptide

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ROUTE SCOUTING FOR APIs

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Ardena offers route scouting, route comparison, development and scale up of a new synthesis route for the drug substance. They can develop more efficient synthetic routes with a reduced number of process steps, starting from lower cost raw materials.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Route Scouting

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API SCALE-UP SERVICES

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Ardena can scale up the process in their GMP kilo lab and in their state of the art GMP pilot plant facilities at Oss and Sodertalje having reactor capacity ranging from 1 L to 1000 L scale.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

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POLYMORPHIC FORM STUDIES

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Ardena's solid state research team investigates the solid form of the drug substance aiming to identify a stable salt or polymorphic form, with acceptable bioavailability and bulk properties.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

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FORMULATION DEVELOPMENT FOR CLINICAL SUPPLY

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Ardena provides support to develop and manufacture a product from molecule to clinic. They support the entire process from formulation development through to pilot-scale manufacturing, scale up and GMP production of small-scale clinial trial supplies.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Clinical Supply

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MODIFIED RELEASE FORMULATION DEVELOPMENT

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Ardena, having formulation development expertise, also offers manufacture capabilities for the following dosage forms such as modified release pellets & microspheres, spray dried powders, powder blends for reconstitution, over-encapsulated products, etc.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Controlled / Immediate / Modified Release

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FORMULATION DEVELOPMENT FOR PELLETS

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Ardena provides formulation development & manufacturing services for pellets & microspheres. They also have capabilities for other dosage forms such as modified release pellets, spray dried powders, powder blends, over-encapsulated products, etc.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Granule / Pellets

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INTRANASAL FORMULATION DEVELOPMENT

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Ardena, has the capabilities to develop formulations for a very broad range of administration routes, such as intranasal, oral, topical, ocular and intravenous.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Inhalation / Nasal

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SOLUBILITY ENHANCEMENT METHODS & TECHNOLOGIES

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Ardena offers solubility enhancement methods and technologies, including nanosuspensions, amorphous solid dispersions, lipid-based formulations, etc. to increase the dissolution rate or apparent solubility at the site of absorption.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Solubility Assessment & Enhancement

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LIPID FORMULATION DEVELOPMENT

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At Ardena, lipid formulations are developed via a science-based approach, carefully balancing solubilising capacity. Their lipid-based delivery systems range from simple oil solutions to complex mixtures of oils, surfactants, co-surfactants & cosolvents.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Lipid Formulation

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MICROSPHERES FORMULATION DEVELOPMENT

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Ardena's nanomedicine expertise encompasses formulation development for microspheres, process and analytical development, GMP manufacturing and dossier development.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Liposome / Microsphere / Nanoparticle

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FORMULATION DEVELOPMENT SERVICES

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Ardena provides drug product services through dedicated formulation development, analytical, manufacturing services through their fully equipped drug product development facility with separate formulation development & analytical laboratories.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Overview

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FORMULATION SCALE UP

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Ardena supports the entire process from formulation development through to pilot-scale manufacturing, scale up and GMP production. They also offer analytical development and quality control (QC) testing.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Scale-Up Capabilities

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FORMULATION DEVELOPMENT FOR NANOSUSPENSION

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Ardena offers nanosuspension formulation development with the identification of a suitable stabiliser system. In addition to a broad range of milling systems, Ardena has technologies to convert liquid nanosuspensions into solid forms.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Suspension

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TOPICAL FORMULATION DEVELOPMENT

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Ardena has the capabilities to develop formulations for a very broad range of administration routes, such as topical, intranasal, oral, ocular and intravenous.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Topical

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CONTRACT MANUFACTURING FOR CHIRAL MOLECULES

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Ardena offers expertise with long synthesis routes & the production of complex chiral molecules from their GMP plants, suited for the supply of batches for toxicology studies, early & late-stage clinical trials, & for low volume commercial manufacturing.

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Pharma Service: API Manufacturing

Category: Chiral Synthesis

Sub Category: Overview

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SHORT PATH DISTILLATION SERVICES

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Ardena offers short path distillation for the purification of very high boiling and thermally labile compounds. They perform short path distillation to meet research and GMP requirements. They have capacity to purify up to 100 kg per 24 hours.

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Pharma Service: API Manufacturing

Category: Distillation / Liquid API

Sub Category: Overview

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MANUFACTURING OF HIGH POTENT APIs

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Ardena’s drug substance unit has capabilities & expertise in manufacturing highly potent drug substance, including steroids. Their production facility has containment capabilities that comply with occupational exposure band C (0.1-1 mg/m3) requirements.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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CONTRACT MANUFACTURING FOR PEPTIDES

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Ardena offers comprehensive peptide development and production capabilities. Their GMP facilities comprise of manufacturing labs for peptide synthesis and purification, LAF hood, and a grade C cleanroom.

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Pharma Service: API Manufacturing

Category: Protein / Peptide

Sub Category: Overview

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ULTRA & NANOFILTRATION CAPABILITIES

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Ardena has capacity for ultra- and nanofiltration of small molecules, (bio)conjugates, polymers, and nano- or micro-particles. This enables them to remove organic impurities and solvents, salts, and to carry out buffer exchanges for the product.

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Pharma Service: API Manufacturing

Category: Separation & Purification

Sub Category: Ultrafiltration / Nanofiltration

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API GMP MANUFACTURING SERVICES

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Ardena offers GMP manufacturing service with equipments consists of reactors from 1L up to 1000L (HC and GLS), autoclave reactors, liquid, slurry, and powder dosing devices, agitated work up tanks (700 L), filters, filter dryers, etc.

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Pharma Service: API Manufacturing

Category: GMP Manufacturing

Sub Category: Overview

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PACKAGING & LABELLING FOR CLINICAL SUPPLIES

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Ardena offers packaging and labelling solutions for clinical supplies based upon the clinical study design, they customise and optimise the label & packaging strategy to meet timelines and desired study complexity.

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Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Packaging & Labeling

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CONTRACT MANUFACTURING FOR SOLUTIONS

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Ardena offers GMP and non-GMP drug product manufacturing services in a variety of dosage forms, including solutions and nano-suspensions, powder and granule filled capsules, semi-solid and liquid filled capsules, topical products, tablets, etc.

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Pharma Service: Drug Product Manufacturing

Category: Solution

Sub Category: Overview

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CONTRACT MANUFACTURING FOR NANO-SUSPENSIONS

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Ardena offers GMP and non-GMP drug product manufacturing services in a variety of dosage forms, including: nano-suspensions and solutions, powder and granule filled capsules, semi-solid and liquid filled capsules, topical products, tablets, etc.

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Pharma Service: Drug Product Manufacturing

Category: Suspension

Sub Category: Overview

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CONTRACT MANUFACTURING FOR HARD CAPSULES

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Ardena offers GMP and non-GMP drug product manufacturing services in a variety of dosage forms, including powder and granule filled capsules, semi-solid and liquid filled capsules, solutions & nano-suspensions, topical products, tablets, etc.

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Pharma Service: Drug Product Manufacturing

Category: Capsule

Sub Category: Hard Capsule

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TABLET CONTRACT MANUFACTURING SERVICES

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Ardena offers GMP and non-GMP drug product manufacturing services in a variety of dosage forms, including: tablets, powder and granule filled capsules, semi-solid and liquid filled capsules, nano-suspensions and solutions, topical products, etc.

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Pharma Service: Drug Product Manufacturing

Category: Tablet

Sub Category: Overview

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CONTRACT MANUFACTURING FOR PELLETS

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Ardena offers drug product manufacturing capabilities to manufacture the variety of dosage forms modified release pellets and microspheres, spray dried powders, powder blends for reconstitution, over-encapsulated products, etc.

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Pharma Service: Drug Product Manufacturing

Category: Granule / Pellet

Sub Category: Overview

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MODIFIED RELEASE PELLETS MANUFACTURING

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Ardena provides expertise in drug product manufacturing service for a variety of dosage forms, as well as offering specialist capabilities such as the manufacture of modified release pellets, spray dried powders and over-encapsulated drugs, etc.

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Pharma Service: Drug Product Manufacturing

Category: Granule / Pellet

Sub Category: Modified Release

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GMP MANUFACTURING FOR NANOPARTICLES

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Ardena's nanomedicine expertise offer GMP manufacturing for nanoparticles along with formulation, process & analytical development, dossier development. They offer nanoscale/nanostructured materials to impart unique pharmacokinetic & therapeutic effects.

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Pharma Service: Drug Product Manufacturing

Category: Liposome / Microsphere / Nanoparticle

Sub Category: Overview

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PACKAGING & LABELLING FOR CLINICAL SUPPLIES

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Ardena's labelling services for clinical trial supplies include preparation and translation of multi-language label text, label (printing) activities with: single layer labels, booklet labels, peel-off, (re)labelling for an expiry date extensions, etc.

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Label

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CLINICAL SECONDARY PACKAGING

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Ardena's customised clinical packaging capabilities include: drug product secondary packing, storage of primary and secondary packaged materials, warehousing with temperature controlled storage areas, dedicated rooms for label printing & packaging, etc.

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Secondary Packaging

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CLINICAL PACKAGING SERVICES FOR BOTTLES

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Ardena offers packaging & labelling services for clinical trial supplies in different types of containers such as bottles, tubes, sachets with primary packaging of in-house or externally produced drug product (capsules, tablets).

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Bottle

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CLINICAL PACKAGING SERVICES FOR TUBES

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Ardena offers packaging & labelling services for clinical trial supplies in different types of containers such as tubes, bottles, sachets with primary packaging of in-house or externally produced drug product (capsules, tablets).

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Tube

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CLINICAL PACKAGING SERVICES FOR SACHETS

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Ardena offers packaging & labelling services for clinical trial supplies in different types of containers such as sachets, tubes, bottles with primary packaging of in-house or externally produced drug product (capsules, tablets).

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Pouch / Sachet / Stick Pack

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CLINICAL TRIAL PACKAGING SERVICES

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Ardena offers a full range of primary & secondary packaging for a wide range of container types along with other services such as randomisation, blinding & unblinding services for clinical trials, sourcing and repacking services for comparator products.

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Overview

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CONTRACT SECONDARY PACKAGING SERVICES

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Ardena has more than 20 years of experience in providing both primary and secondary packaging services for a wide range of container types such as bottles, tubes, sachets etc.

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Pharma Service: Packaging

Category: Contract Services

Sub Category: Secondary Packaging

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BIOANALYTICAL SERVICES FOR BIOMARKERS

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Ardena offers a complete range of bioanalytical services for all the biomarker research needs from discovery & screening for novel biomarkers through to the bioanalysis of biomarkers in regulated clinical trials.

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Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Bioanalytical & Biomarker Testing Services

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BIOANALYTICAL SERVICES - CLINICAL PHASE I-IV

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Ardena offers the full range of bioanalytical services, from discovery research through to GLP compliant preclinical assessments. Ardena’s GCP-compliant bioanalytical services can support regulatory clinical studies through phase I-IV.

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Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Bioequivalence / Clinical / Pre-Clinical Testing

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PHARMACOKINETICS SERVICES

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Ardena provides assay based in-vitro pharmacology & PK services, ADME studies like absorption, distribution to identify potential drug-drug interactions (e.g. solubility, metabolic stability, membrane permeability, CYP interaction, etc).

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Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Calculation and Modeling of Pharmacokinetic Parameters

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CELL BASED SCREENING ASSAYS

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Ardena’s drug discovery services uses in-vitro cell-based screening assays to study the interaction of the compound(s) of interest with their potential target. They also provide assay based in-vitro pharmacology and PK services.

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Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Immunoassay & Cell Based Assay

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ANALYTICAL METHOD DEVELOPMENT

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Ardena’s state-of-the-art, GMP qualified, equipment and facilities offer analytical method development services to support the development of drug substances and complex bulk drug products like nano-formulations.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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BIOANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Ardena’s GCP-compliant bioanalytical services include method development and validation.They create the most robust, sensitive assays possible by using their state-of-the-art instrumentation to support the regulatory clinical studies through phase I-IV.

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Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Method Development and Validation

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Pharma Services Category of Ardena