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   HWI group - services for active ingredients, medicinal products and
medical devices

rubric : service provider

HWI group provides a wide range of inividual and specialised pharmceutical services for the pharma, medtech and biotech industries, in paticular for active ingredients, medicinal products and medical devices

Benefit from our long-​standing experience in laboratory services, reference standard services, vigilance and quality services, API assessment and drug development as well as regulatory affairs services.

The HWI group
Laboratory and Consultancy Services
Group Profile

The HWI group consists of :


HWI pharma services GmbH in
Rülzheim and Frankfurt

- Laboratory Services
- Vigilance- und Quality Services
- Innovative formulations

Rheinzaberern Str. 8
76761 Rülzheim

+49 7272 7767-0
+49 7272 7767-11


HWI development GmbH in

- API Charakterisierung
- Drug Development



HWI regulatory services GmbH in Planegg / Martinsried

- Regulatory Affairs
- Medical Devices
- Life-Cycle-Management

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
  • Vigilance & Quality Services

      • Pharmacovigilanz and Vigilanz Services
      • GVP & GDP, GVP Services
      • Setup of quality managem and
        Pharmacovigilanz systems
      • Batch release(6 QPs), GMP audits


  • Regulatory Affairs Services for Drug Substances, Drug Products and Medical Devices

  • Life Cycle Management

  • API characterization

  • Drug Development / Innovative Formulations

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

Viglilance & Quality Services

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

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

Development Services / Innovative Formulations

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

  • 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                Preparation and submission of variations and renewals
                   • Dossier updates

  • Strategic and regulatory consultancy in R&D projects

Group Profile


HWI pharma services
offers services for the pharmaceutical, biotech and medtech industries. Our Ruelzheim site has more than 25 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 cpmpliance
We have our own GVP-compliant pharmacovigilance system and offer extensive support regarding the safety of medicinal products and medical devices. 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 und Planegg / Martinsried
Together with the development and manufacture of clinical trial samples and small scale batches by HWI development GmbH and the regulatory services for medicinal products and medical devices from HWI regulatory services GmbH, the HWI group offers a wide range of services for active substances, medicinal products and medical devices, all from a single source.



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