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  Companies - Service Provider - Product Programs - Measuring Units - Technologies - Applications
 

   rubric : service provider

The HWI group is a comprehensive service provider which covers the entire life cycle
of medicinal products, medical devices and other related products

Content
The HWI group
Rubric / Technologies
Laboratory and Consultancy Services product range reference standards  
Group Profile

The HWI group consists of:


Rubric / Technologies  

 

 

    • service provider

    • Laboratory Services
    • Reference standards for quality control
    • Vigilance & Quality Services
      • Pharmacovigilanz Services
      • GMP & GDP, GVP services
      • Quality management services
      • Batch release(6 QPs), GMP audits
    • Regulatory Affairs Services for Drug Substances, Drug Products and Medical Devices
    • Life Cycle Management
    • API characterization
    • Drug Development

 

Laboratory and Consultancy Services

Laboratory Services Reference Standards Viglilance & Quality Services Development Regulatory Affairs


Laboratory Services    -    HWI pharma services GmbH



HWI pharma services GmbH
Rheinzaberern Str. 8
76761 Rülzheim
Deutschland

 Telefon
+49 7272 7767-0
Telefax
+49 7272 7767-11

E-Mail
info@hwi-group.de
Homepage
www.hwi-group.de/home.html


 

Quality control for drug substances, intermediates, excipients & drug products as well as medical devices and
drug-device combination products

Development & Validation Routine Testing Purity Testing – Trace Analysis Consulting Covering all Topics in the CMC Field
• Chromatographic   methods

• Titration testing   procedures

• for assay, purity and   drug release
• Batch release testing /   quality control

• Stability studies and   stability storage   facilities (25⁰C/60%,   30⁰C/65%, 30⁰C/75%,   40⁰C/75%, 2-8⁰C)

• Photostability studies
• Extractables/
  leachables   studies

• Potentially genotoxic   impurities   (PGI)

• Cleaning validation   studies
• Elemental impurities   (EI)
• Residual solvents (RS)

• Troubleshooting & root   cause analysis : impurities
  from production processes

• Structure elucidation using   mass spectroscopy and     NMR

• Modern analytical   physical   methods SEM-EDX,   Raman, XMT
• Comprehensive risk based   evaluation of product quality   regarding analytical questions

• Review of specifications,   analytical procedures,   validation reports according to   up-to-date scientific   knowledge and regulatory   requirements

• Gap analysis of module 2.3/3   together with our regulatory,   drug development and   production experts

Reference Standards ServicesHWI pharma services GmbH

>25 years of experience: synthesis, isolation, qualification of pharmaceutical reference standards

Qualification of pharmaceutical reference standards including dossier preparation for submission in 3.2.P.5.6
  assay standards

Assay standards

  • Primary reference standards (complete documentation)
  • Working standards (batch-related CoA)

Ident-purity standards

• Long-term experience in global RS distribution: customized portioning to your workflow needs in different quality   packages at a favourable price-performance ratio

Our reference standards meet all legal and regulatory requirements in the GMP environment

product range reference standards


Viglilance & Quality Services - HWI pharma services GmbH

Pharmakovigilance Quality Management Batch Release for Medicinal Products

Adoption of responsibility as
  EU-QPPV and graduated plan   officer (“Stufenplanbeauftragter”)
  by our own staff

Case processing, periodic reports   and risk management plans

Signal Management

Review and gap-analysis of your   pharmacovigilance system

Compilation and maintenance of   the pharmacovigilance system   master file (PSMF)

Comprehensive advice and support
  in meeting requirements of quality   management according to the   German Drug Law (AMG),   Ordinance on the Manufacture of   Medicinal Products and Active   Substances (AMWHV) and
  EU- GMP guidelines

Implementation, management and   maintenance of a quality assurance   system (incl. pharmacovigilance   system)

Application for manufacturing,
  import and wholesale authorisations

Planning and performance of GMP-,   GDP- and GVP-audits and
  self-inspections

Batch release by a Qualified Person   from HWI or as external Qualified   Person

Development Services – HWI development GmbH


API characterization

Development of solid oral dosage forms

            Tablets, coated tablets, mini-tablets, hard capsules
            Granules, pellets, powders

• Handling of high potent and narcotic drug substances
Manufacturing of batches up to 25 kg
Prolonged-release formulations (platform technology)
GMP and non-GMP development
Phase I and II clinical samples manufacturing
Dry powder inhaler development and testing (platform technology)
Trouble shooting (drug substance and drug product)
Risk-based drug development approach, design of experiments (DoE)


Regulatory Affairs Services – HWI regulatory services GmbH


Regulatory services (development | submissions | consultancy)

Life cycle management
               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

Strategic and regulatory consultancy in R&D projects
Combination products (drug-device combinations)
Medical devices




Group Profile

 

Group Profile

HWI pharma services GmbH was founded in 1991. We are relied upon by companies that appreciate contact on equal terms. With our long-standing experience and our striving for improvement, we provide laboratory and consultancy services in the divisions

  • Laboratory Services
  • Reference Standards
  • Vigilance and Quality Services
  • Development
  • Regulatory Affairs

at a high quality standard. In your cooperation with us companies perceive us as a fair, reliable and transparent partner. For this is the only way to develop long-term, trustful relations.


 

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