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   HWI group - innovative technologies and services for API and medicinal products

rubric : service provider
 


HWI group offers a wide range of individual and specialised pharmaceutical services for pharma & biotech,
especially for active ingredients and medicinal products.

Benefit from our long-standing experience in laboratory services, pharmacovigilance and QP services, API assessment as well as drug development.
In regulatory affairs services we work together with an external partner.



Content
The HWI group
The Service Provider - Technologies
Laboratory and Consultancy Services
Group Profile & contact adress

The HWI group consists of :

 



HWI pharma services GmbH in
Rülzheim and Frankfurt

- Laboratory Services
- Pharmacovigilance and QP-services
- Innovative formulations (parenteral, intranasal)



HWI development GmbH in
Appenweier


- API Charakterisierung
- Drug Development (solid formulations)
- Serialisation, labelling, packaging, small- and
clinical trial batches

 

The Service Provider - Technologies  


  • Laboratory Services

      • Method development and validation
      • Purity testing of particular impurities – trace analysis
      • Structure elucidation
      • Trouble shooting (root cause analysis)
      • Extractables & Leachables testing
      • Batch release and stability testing
      • Reference standards for quality control
  • Pharmacovigilance & QP Services

      • Pharmacovigilance
      • GMP & GDP, GVP services / advice
      • Establishment of quality management and   pharmacovigilance systems
      • Batch release(6 QPs), GMP audits




  • Life Cycle Management

  • API characterization

  • Drug Development / Innovative Formulations (parenteral, nasal, solid, semi-solid)
  • Serialisation, labeling, packaging, small batches und clinical trial batches

Laboratory and Consultancy Services

 
Laboratory Services Viglilance & Quality Services Development Regulatory Affairs

Laboratory Services   

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 Reference Standards
• 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

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


Pharmacovigilance & QP services


Pharmacovigilance 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

Drug Development Services / Innovative Formulation


  • API characterization

  • GMP and non-GMP development and manufacturing of:
    solid dosage forms: tablets, coated tablets, mini tablets, dragees, hard capsules, granules, pellets, powders
    semi-​solid dosage forms: creams, gels, emulsions
    liquid dosage forms: solutions, nano- and micro suspensions, lyophilisat
    parenteral dosage forms
    dosage forms with modified active-​ingredient release

  • handling of toxic and high potent APIs up to OEB 5
  • manufacturing of small and clinical trial batches
  • trouble shooting (drug substance and drug product)
  • Primary- and secondary packaging inclusive labelling and serialisation



Group Profile &Contact Adress

 

Contact adress

HWI pharma services GmbH
Rheinzaberern Str. 8
76761 Rülzheim
Germany

phone
+49 7272 7767-0
telefax
+49 7272 7767-11

e-mail
info@hwi-group.de
Homepage
https://www.hwi-group.de/en/home.html

Gruoup profile

HWI pharma services
offers services for the pharma & biotech industries. Our Ruelzheim site has more than 30 years of experience in the development and validation of analytical methods, trace analysis, troubleshooting, quality control and stability testing of active substances, excipients and medicinal products, as well as drug-related products and medical devices. We are GMP- and FDA-certified and hold a manufacturing licence for the release of clinical and market batches. Our reference standard concept extends from a wide range of qualified primary and working standards to complete just-in-time supplies for quality control laboratories.

GVP compliance

We have our own GVP-compliant pharmacovigilance system and offer extensive support regarding the safety of medicinal products. Our competent team advices on how to fulfil quality-management requirements in accordance with legislation.

The Frankfurt site

Our Frankfurt site specialises in the development of highly innovative medicinal products with potent active substances up to OEB class 5 for oral and parenteral administration to patients in a wide range of indications.

The sites Appenweiler (HWI development GmbH)
Our Appenweier site is specialised in the development of solid and semi-solid formulations and to manufacture clinical trial samples and small scale batches including the whole logistic.





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