Lifecycle Management

Lifecycle Management
Product Description

Compilation, review and maintenance of the  CTD dossier modules 1.8 and 3

  • compilation, revision and maintenance of package leaflets
  • summaries of product characteristics (SmPCs) and labelling, including adoption of the responsibility as Information Officer (“Informationsbeauftragter”)
  • preparation and submission of variations and renewals ›dossier updates

HWI pharma services GmbH

  • DE
  • 2015
    On CPhI since
  • 2
    Certificates
  • 100 - 249
    Employees
Consultancy
Contract Service
Manufacturer/Innovator
Specifications
  • Supplied from
    Germany
  • Measured In
    piece

HWI pharma services GmbH

  • DE
  • 2015
    On CPhI since
  • 2
    Certificates
  • 100 - 249
    Employees
Consultancy
Contract Service
Manufacturer/Innovator

More Products from HWI pharma services GmbH

  • Laboratory Services

    Product Laboratory Services

    Laboratory Services
    We are your partner for pharmaceutical analysis and quality control. With 25 years’ experience and continuously striving for improvement, we deliver our analytical services for drug substances, drug products, medical devices and drug-device combination products at a high quality level. Alongside the development and validation of analytical methods, batch release testing, stability testing and structure elucidation, the risk-based and solution-oriented consultation of our clients according to current regulatory requirements is one of our core competencies.

    With our long-term experience in trace analysis we offer the complete management and laboratory services for extractables & leachables studies, cleaning validation studies and the investigation of genotoxic as well as elemental impurities. We support you with troubleshooting in production issues and offer you express services in root cause analysis using modern screening methods for objectionable organic and inorganic impurities as well as particles.
    More than 40 employees in our analytical laboratories implement our clients’ requirements, target-oriented and efficiently, supported by lean management tools. With interdisciplinary teams and professional project management, we ensure your complex projects are successful. Our laboratories are GMP-certified and we have a manufacturing license for the release of clinical batches  and market batches.

    Quality Control of Drug Substancesand Drug Products
    • Method development and validation
    • Batch release
    • Stability studies
    • Impurities from API synthesis and degradation products
    Trace Analysis
    • Extractables & leachables:investigation of packaging materials
    • Potentially genotoxic impurities 
    • Troubleshooting in production issues 
    • Residual solvents

    Quality Control of Medical Devices
    Consulting on CMC-related Topics
  • Method Development/ Validation

    Product Method Development/ Validation

    Laboratory Services & Quality Control
    Our services in summary:
    • Analytical method development and validation
    • Quality control services for drug substances, drug products and medical devices
    • Structure elucidation
    • Trace analysis: extractables & leachables studies, genotoxic impurities, cleaning validation studies, elemental impurities
    • Consulting on CMC-related topics 
    • Root cause analysis of contaminations in production issues 
    Laboratory Services
    Quality Control of Drug Substances and Drug Products

    Method development and validation
    We develop and validate analytical methods for identity testing, assay, related substances and in vitro dissolution testing for drug substances, excipients, intermediates and finished drug products, according to international guidelines and GMP requirements. For that purpose, we implement state-of-the-art analytical methods and chromatographic separation techniques (HPLC, GC) using various  detectors such as UV/DAD detection, fluorescence detection, refractive index detection, evaporative light scattering detection, conductivity detection, flame ionisation detection and mass selective detection. Validation protocols and reports can be issued in German, English or French and can be directly incorporated into marketing authorisation dossiers.

    Batch release
    We have a manufacturing authorisation according to the German Drug Law (AMG) § 13 (1), for the batch release of drug substances and drug products as well as clinical batches. We conduct analytical testing for the EU release of drug products.

    Stability studies

    Impurities from API synthesis and degradation products

    • Development and validation of chromatographic testing procedures for purity testing of drug substances and drug products as well as medical devices and drug-device combination products
    • Development of stability indicating methods including stress testing according to ICH Q3A & Q3B
    • Identification of impurities and related substances using mass spectrometry (GC-MS/LC-HRMS) and NMR
    • Isolation of impurities using (semi-)preparative LC
    • Qualification and distribution of purity reference standards
    • Consulting for setting up specifications & toxicological evaluation of impurities

    Trace Analysis
    • Extractables & leachables:
    • investigation of packaging materials
    • Potentially genotoxic impurities
    • Troubleshooting in production issues
    • Residual solvents
    • Quality Control of Medical Devices

    Consulting on CMC-related Topics


  • Impurities

    Product Impurities

    Impurities from API synthesis and degradation products
    • Development and validation of chromatographic testing procedures for purity testing of drug substances and drug products as well as medical devices and drug-device combination products
    • Development of stability indicating methods including stress testing according to ICH Q3A & Q3B
    • Identification of impurities and related substances using mass spectrometry (GC-MS/LC-HRMS) and NMR
    • Isolation of impurities using (semi-)preparative LC
    • Qualification and distribution of purity reference standards
    • Consulting for setting up specifications & toxicological evaluation of impurities
    Trace AnalysisExtractables & leachables:
    investigation of packaging materials
    • Individual set-up of extractable studies based on packaging material and product composition
    • Identification of extractables using in-house LC-HRMS and GC-MS methods
    • Toxicological evaluation of extractables and potential leachables
    • Development and validation of leachables method based on results of extractable studies
    • Migration studies within stability testing for investigation of leachables
    Potentially genotoxic impurities
    • Development of control strategies according to ICH M7
    • Review of synthesis pathways
    • Trace analysis and ultra-trace analysis including analytical method development and validation forpotentially genotoxic impurities (PGIs)
    • Setting up specifications according to TTC approach
    Troubleshooting in production issuesExpress services for investigation of production issues including root cause analysis
    • Structure elucidation of organic impurities using in-house screening methods with LC-HRMS, GC-MS and LC-SPE / NMR
    • Investigation of inorganic impurities using SEM-EDX and ICP-OES/MS techniques
    • Determination of particles using X-ray micro/nanotomography, SEM-EDX and RAMAN microscopy /chemical imaging   
    • Particle size distribution using Malvern Mastersizer ® & Helos ®   
    Residual solvents    

    • Product-specific validation for residual solvents according to Ph. Eur. 2.4.24 and ICH Q3C
    • In-house method for high-price samples using very low sample amounts   
    • Identification of unknown residual solvents using GC-MS and NIST database
  • Structure Elucidation

    Product Structure Elucidation

    Structure elucidation of unknown impurities (degradation products, synthesis by-products, root cause of impurities within production lines)
    • Project leaders with years of experience in the CMC field
    • GAP analysis with regulatory and analytical advisory services
    • QToF (time of flight) mass spectrometer for determination of exact molecular masses (high resolution mass spectrometry, HR-MS) for complex analytical challenges, e. g. structure elucidation, hyphenated to UHPLC
    • Triple Quad mass spectrometer (Quattro Micro) for routine testing, hyphenated to UHPLC
    • 5975C XL mass spectrometric detector, hyphenated to GC
    • LC-NMR technics (with external partner)
  • Stability Studies

    Product Stability Studies

    Stability studies
    • ICH and ongoing stability studies
    • In-use stability studies
    • Photostability studies
    • Matrixing & bracketing designs
    • Stability studies of controlled substances (narcotics) 
    • Comprehensive capacities for GMP-compliant stability storage
    • Consulting on stability concepts and shelf life specifications

  • Excipients and Drug Formulation

    Product Excipients and Drug Formulation

    Drug Development
    Our methodological approach to development has proven to be as successful in investigating product formulations as it has been in the processes of product manufacturing. The starting point of our development activities is always the drug substance (API).

    Drug substance (API
    )
    • Search and sourcing
    • Chemical and physicochemical properties
    • Evaluation of API qualities on:
    • Particle size distribution
    • Polymorphism
    • Compatibility
    • Solubility
    • Impurity profile
    • Micronisation 
    Product development and manufacturing
    • Development of new drug products
    • Product reformulation
    • Manufacture, primary packaging, distribution and release of clinical batches, procurement of comparator medication
    • Manufacture of GMP pilot batches and stability batches
    • Drug product transfer services
    QbD drug development approach
    • Definition of Quality Target Product Profile (QTPP) with the client
    • Risk analysis on product development and manufacturing process
    • Feasibility studies
    • Design of experiments (DoE) approach
    • First scale-up of prototype batches
    • Implementation of lean development tools 
    Dosage Form & Equipment
    In our new technical laboratory we develop and manufacture drug products according to ICH guidelines in small to medium-sized batches. We can also carry out work with hazardous substances.
    Dosage forms
    • Tablets, mini tablets, film-coated tablets, sugar-coated tablets
    • Granules, pellets, powders 
    • Prolonged-release formulations (platform technology)
    • Dry powder inhalers (platform technology)
    • Oral liquid formulations
    GMP & SHE
    Handling sensitive and hazardous substances requires special protection, both for the substances themselves and for the people who deal with them. We meet this challenge by applying approved and innovative safety concepts.

    We provide
    • Manufacturing licence for pilot batches and clinical batches 
    • Established SHE management system
    • Handling of drug substances up to OEB level 4
    • Flex isolator technology
    • GMP-certified analytical laboratory

    Modern analytical methods for development and troubleshooting
    • XMT/XNT (X-ray micro/nanotomography, micro-CT)
    • PXRD (X-ray powder diffraction): crystallinity, polymorphism
    • RAMAN microscopy and chemical imaging    
    • SEM-EDX (scanning electron microscopy in combination with X-ray fluorescence spectroscopy)   
    • BET (specific surface area and porosity testing)   

  • API characterization

    Product API characterization

    API Characterisation & Drug Development

    Whether you wish to develop new products, improve existing ones or optimise quality, HWI development GmbH provides comprehensive support in the development of different pharmaceutical formulations.  
    With our highly qualified staff and the ambition to remain open to new paths, we are a successful, competent partner for all companies working in this field. We meet our clients’ expectations effectively and reliably, through optimal project planning and implementation. To this end we work with tools from lean management and lean development.  
    We not only consistently apply the methods and processes of this streamlined, holistic management system, but also help to develop them further. Especially attractive for our clients is the energy and passion that we bring to creating marketable solutions.  

    Drug substance (API)
    • Search and sourcing
    • Chemical and physicochemical properties
    • Evaluation of API qualities on:
    • Particle size distribution
    • Polymorphism
    • Compatibility
    • Solubility
    • Impurity profile   
    • Micronisation    
     


  • Finished dosage forms

    Product Finished dosage forms

    Product development and manufacturing
    • Development of new drug products
    • Product reformulation
    • Manufacture, primary packaging, distribution and release of clinical batches, procurement of comparator medication
    • Manufacture of GMP pilot batches and stability batches
    • Drug product transfer services

     QbD drug development approach
    • Definition of Quality Target Product Profile (QTPP) with the client
    • Risk analysis on product development and manufacturing process
    • Feasibility studies
    • Design of experiments (DoE) approach
    • First scale-up of prototype batches
    • Implementation of lean development tools 

    Dosage Form & Equipment

    In our new technical laboratory we develop and manufacture drug products according to ICH guidelines in small to medium-sized batches. We can also carry out work with hazardous substances.

    Dosage forms
    • Tablets, mini tablets, film-coated tablets, sugar-coated tablets
    • Granules, pellets, powders
    • Prolonged-release formulations (platform technology)
    • Dry powder inhalers (platform technology)
    • Oral liquid formulations
  • Medical Device and combination products

    Product Medical Device and combination products

    Apart from the MA of medicinal products our expertise comprises the certification of medical devices.We support you in the development and market access of medical devices and combination products. Demarcation and classificationYou are welcome to benefit from our experience in providingexpert reports on demarcation and classification to bepresented to authorities or Notified Bodies. If you wish,we also attend your internal discussion and decision-makingconcerning demarcation and classification issues for yourproduct. Clinical evaluationThe clinical performance and safety of a medical device isevaluated based on clinical data. We prepare the clinicalevaluation based on both, literature and clinical trial reports. Biological safetyA key prerequisite for the certification of medicinal productsis the assessment of biological safety. We establish thisassessment or provide a corresponding report on your behalf. Risk analysisWith our knowledge in the field of biological and clinicalsafety, we are able to support you in compiling or updatingthe risk analysis in this domain.  Technical documentationTo provide evidence that a medical device meets the basicrequirements of rules and regulations, we compile, reviewand maintain your technical documentation. CertificationIt is advisable to contact the Notified Body already in an earlyphase of the project in order to ensure targeted and thereforeefficient development. We offer you our support in contactingNotified Bodies, preparing scientific advice meetings, supervisingthe certification process, reviewing your documentation, and in the entire development of your product.  Drug-device combination products Drug-device combination products are either governed bythe rules and regulations concerning medicinal products or by those concerning medical devices. This depends on whichcomponent causes the principal action. Our services cover theentire demarcation, development and life cycle of such products, ranging from consulting services alone to the compilation, editing and assessment of documentations right through toexpert opinions and biological as well as clinical evaluationsrequired to prove conformity. For products that might beclassified as medicinal products (borderline products), we compile position papers on demarcation. Devices composed of substances Devices composed of substances have to fulfil rules andrequirements for medicinal products, additionally. Especiallytoxicological and pharmacological aspects has to regardedas laid down in Annex I to Directive 2001/83/EG. We help ourclients to identify the specific requirements for these products,and compile the corresponding documentation.
  • Regulatory Affairs Services

    Product Regulatory Affairs Services

    Regulatory Affairs Services & Life Cycle Management The regulatory services for human and veterinary medicinal products provided by i.DRAS GmbH cover the whole product life cycle. These activities range from preclinical development stages to the first submission of the MA dossier and post-marketing activities. Our service promotes all types of regulatory activities, from investigational medicinal products to new, generic or bibliographical applications to achieve MA for new and established drug substances and the corresponding drug products. This includes medicinal products containing herbal as well as chemical entities. Among post-marketing activities we provide our expertise for dossier updates, variations, renewals, line extensions and mutual recognition procedures. Medical devices and drug-device combination products differ in their regulatory requirements compared to medicinal products. We help manufacturers to obtain certification for these products as a prerequisite to European market access. Clinical evaluation, assessment of biological safety and the collation of technical documentation are our particular strengths. Whenever it is necessary to establish whether a product has to be regulated as a medicinal product or medical device, we provide our long-term expertise. As expert partners we oversee the certification of substance-based medical devices and drug-device combination products and all types of due diligence pertaining to dossiers and documents in this context.  
  • Medicinal Products

    Product Medicinal Products

    We provide advice on and support all tasks in the context of development, marketing authorisation (MA) andmaintenance for human and veterinary medicinal products, including the corresponding project management.We ensure a smooth and fast MA. ConsultancyThe generation of medicinal products requires competentregulatory expertise and the consideration of correspondingrequirements from the beginning. We identify the optimalstrategy for your product. It is our pleasure to consult youon the planning and execution of CMC projects, such asGMP synthesis and characterisation of drug substances,formulation development as well as method and site transfers. DevelopmentThe submission of clinical trial applications as well asthe compilation and revision of dossiers for investigationalmedicinal products is part of our competence. For anyoutsourced activity needed, we identify potential partnersfrom our network, also for young biotech- or start-upcompanieswithout own development resources. Marketing authorisationOur expertise comprises all types of MA applications andprocedures for all types of products. We are pleased to findthe optimal MA strategy for your product and prepare allnecessary documents, including summaries and overviews.On your behalf we submit the dossier to the competentauthority, take care of the procedure management andanswer queries. Maintenance The life cycle management of your products is in good handswith us. We coordinate and handle renewals and variations.As a matter of course the control of deadlines for necessaryrenewals and sunset clause dates is part of this responsibility.If you wish, we independently communicate with yourpartners, such as drug substance suppliers and contractmanufacturers, and connect all activities to your internalchange control system. We also take over the complete dossiermanagement for drug substances and products in their lifecycle. All texts for medicinal products (leaflet, SmPC, outerpackaging) are prepared or revised and published in relevantmedia. We check your promotion material for compliance withlegal requirements.
  • Consultation CMC

    Product Consultation CMC

    We stand for international, individual, innovative and intelligent solutions to support your development,registration and marketing authorisation (MA) projects. To do so we accompany our clients through allregulatory activities, whether traditional registration, national and international procedures includingvariations and renewals, dossier updates or the extension of pharmaceutical product lines.The regulatory services for human and veterinary medicinal products provided by i.DRAS GmbH coverthe whole product life cycle. These activities range from preclinical development stages to the first submissionof the MA dossier and post-marketing activities. Our service promotes all types of regulatory activities,from investigational medicinal products to new, generic or bibliographical applications to achieve MA fornew and established drug substances and the corresponding drug products.This includes medicinal products containing herbal as well as chemical entities and biotechnological products.Among post-marketing activities we provide our expertise for dossier updates, variations, renewals, line extensionsand mutual recognition procedures.Medical devices and drug-device combination products differ in their regulatory requirements comparedto medicinal products. We help manufacturers to obtain certification for these products as a prerequisite toEuropean market access. Clinical evaluation, assessment of biological safety and the collation of technicaldocumentation are our particular strengths. Whenever it is necessary to establish whether a product hasto be regulated as a medicinal product or medical device, we provide our long-term expertise.As expert partners we oversee the certification of substance-based medical devices and drug-device combinationproducts and all types of due diligence pertaining to dossiers and documents in this context.

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