Innovative technologies and services
for pharma & biotech

HWI group offers a broad technological and analytical portfolio for the development, manufacturing and analytical testing of medicinal products with small and large molecules.

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Laboratory services with
a focus on product development

Our strength is the development and validation of analytical methods, batch release and stability studies, testing concepts for impurities and in solving complex analytical issues.

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Formulation development for
small and large molecules

The HWI technology platform offers innovative solutions for fast and cost-efficient development of parenteral, intranasal and oral formulations for small and large active ingredients.

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Digitalised service concepts
in pharmacovigilance

We take over operative activities and advise on pharmacovigilance in the life cycle and clinical trials of medicinal products and medical devices. We digitalise your PV processes and optimise your established systems.

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End-to-end service concept

  • Auswahl: Value-Chain
  • API
  • CMC development
  • Non-Clinic
  • Phase 1
  • Phase 2
  • Phase 3
  • MA
  • Lifecycle
Drug development

Drug development

Development of solid, semi-solid and liquid dosage forms for oral, topical and parenteral application.

  • Formulation development with known and new API (NCEs), small and large molecules
  • Analytical method development and validation for API and registered products
  • Process development and scale-up
  • Formulation of poorly soluble API
  • Containment for high-potent API (up to OEB5)
Dosage forms
  • Tablets, dragées, hard capsules, pellets, granules, powder
  • Matrix tablets for modified / sustained release
  • Solutions, micro-​ and nanosuspensions, lyophilisates
  • Creams, oleo and hydrogels, emulsions
  • Nasal sprays, parenterals

 

Silvia Oettl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Clinical trial manufacturing

Clinical trial manufacturing

Manufacturing, Packaging, approval testing, QP batch release and distribution of clinical investigational medicinal products for solid, semi-solid and liquid dosage forms.

  • Manufacturing of non-sterile solutions, micro- and nanosuspensions up to 100 kg batch size
  • Manufacturing of oral solid dosage forms up to 75 kg batch size
  • Customised primary and secondary packaging
  • Labelling of primary and secondary packaging
  • Randomisation
  • QP batch release
  • GMP release- and stability testing (according to ICH)
  • Handling of narcotic drugs up to10 kg
  • GDP transport to study center

 

Silvia Oettl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Small batches

Small batches

For registered products, we take over the manufacturing, labelling, packaging and serialisation of small and medium batch sizes.

  • Manufacturing of non-sterile solutions, micro- and nanosuspensions up to 100 kg batch size
  • Manufacturing of oral solid dosage forms up to 75 kg
  • Customised primary and secondary packaging
  • Serialisation (TraceLink)
  • Procurement of packaging materials (labels, folding boxes, brochures, etc.)
  • Security features (e.g. tamper-​proof labels)

Siliva Oettl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Analytics

Analytics in product development

We are experts in pharmaceutical analytics and offer in the context of product development:

  • Physical and chemical testing of active substances, excipients and packaging materials
  • Method development and validation (identity, content, purity, in vitro dissultion) for small and large molecules
  • Compilation of release and shelf-life specifications
  • Stress testing and ICH stability testing
  • Chromatographic testing (HPLC, GC, TLC, LC-MS, GC-MS, SEC)
  • Incompatibility testing
  • Testing of technological parameters
  • Tests according to pharmacopoeia
  • Special tests such as PSD, DSC, SEM-EDX, XRPD, XMT
  • Trace analysis including structure elucidation
  • Testing of extractables & leachables
  • Procurement and qualification of reference standards

 

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Analytics

Analytics for investigational medicinal products

For testing and release of clinical investigational medicinal products, we offer:

  • Physical and chemical testing of active substances, excipients and packaging materials
  • Method development and validation (identity, content, purity, in vitro dissultion) for small and large molecules
  • Compilation release and shelf-life specifications
  • Chargenfreigabeprüfung und QP batch release
  • ICH stability testing
  • Trace analysis including structure elucidation
  • Testing of technological parameters
  • Testing of extractables & leachables
  • Procurement and qualification of reference standards

 

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Analytics

Analytics and quality control

For testing medicinal products in the life cycle, we offer:

  • Physical and chemical testing of active substances, excipients and packaging materials
  • Method development and validation (identity, content, purity, in vitro dissultion) for small and large molecules
  • Chargenfreigabeprüfung and QP batch release
  • ICH- and ongoing stability testing
  • Trace analysis including structure elucidation
  • Testing of extractables & leachables
  • Troubleshooting (root cause analysis of quality issues)
  • Procurement and qualification of reference standards for quality control
  • Überarbeitung von Freigabe- und Laufzeitspezifikation

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Analytics

Analytic and quality control

Analytics in product development

We are experts in pharmaceutical analytics and offer in the context of product development:

  • Physical and chemical testing of active substances, excipients and packaging materials
  • Method development and validation (identity, content, purity, in vitro dissultion) for small and large molecules
  • Compilation of release and shelf-life specifications
  • Stress testing and ICH stability testing
  • Chromatographic testing (HPLC, GC, TLC, LC-MS, GC-MS, SEC)
  • Incompatibility testing
  • Testing of technological parameters
  • Tests according to pharmacopoeia
  • Special tests such as PSD, DSC, SEM-EDX, XRPD, XMT
  • Trace analysis including structure elucidation
  • Testing of extractables & leachables
  • Procurement and qualification of reference standards

Analytics for investigational medicinal products

For testing and release of clinical investigational medicinal products, we offer:

  • Physical and chemical testing of active substances, excipients and packaging materials
  • Method development and validation (identity, content, purity, in vitro dissultion) for small and large molecules
  • Compilation release and shelf-life specifications
  • Chargenfreigabeprüfung und QP batch release
  • ICH stability testing
  • Trace analysis including structure elucidation
  • Testing of technological parameters
  • Testing of extractables & leachables
  • Procurement and qualification of reference standards

 

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Regulatory

Regulatory services

We provide regulatory support for the development of medicinal products and combination products up to marketing authorisation and beyond with the following services:

  • Regulatory strategy of product development
  • Support in the preparation of IMPD, IB, marketing authorisation dossiers

 

After marketing authorisation, we provide regulatory support with:

  • Maintenance of registration dossiers
  • Implementation of variations

 

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Non-clinical development

Non-clinical development

For the conduct of non-clinical in vivo and in vitro studies, we produce your formulation on a small scale under GMP conditions. With our partner institute, the Institute of Biochemistry and Molecular Biology at the University of Bonn, headed by Prof. Dr. Häberlein, we provide advice and support in the preclinical strategy and the conduct of preclinical studies on efficacy and tolerability as well as the elucidation of mechanisms of action (mode of action) in cell cultures or in animals.

 

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Pharmacovigilance

Pharmacovigilance of medicinal products and Vigilance medical devices in clinical studies

We are experts and offer services on pharmacovigilance and vigilance of medical devices:

  • Literature research
  • Case processing
  • PV audits
  • Extended EudraVigilance product report message/medicinal product dictionary (XEVPRM/XEVMPD)

 

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Pharmacovigilance

Pharmacovigilance of medicinal products and Vigilance of medical devices in life cycle

We are experts and offer services for pharmacovigilance and vigilance of medical devices:

  • Literature research
  • Case processing
  • Periodic reports (PSURs)
  • Risk management plans
  • Continuous monitoring of the risk-benefit balance
  • Signal management
  • PV audits
  • Extended EudraVigilance Product Report Message / Medicinal Product Dictionary (XEVPRM / XEVMPD)
  • External EU-QPPV
  • External Stufenplanbeauftragte (D)



Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

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Pharmacovigilance

Pharmakovigilanz and Vigilance of medical devices

We provide services for pharmakovigilance and vigilance of medical device in clinical studies:

  • Literature research
  • Case processing
  • PV audits
  • Extended EudraVigilance product report message/medicinal product dictionary (XEVPRM/XEVMPD)

We offer in the life cycle of medicinal products and medical devices:

  • Literature research
  • Case processing
  • Periodic reports (PSURs)
  • Risk management plans
  • Continuous monitoring of the risk-benefit balance
  • Signal management
  • PV audits
  • Extended EudraVigilance Product Report Message / Medicinal Product Dictionary (XEVPRM / XEVMPD)
    External EU-QPPV
  • External Stufenplanbeauftragte (D)

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

learn more

Regulatory

Regulatory services

We provide regulatory support for the development of medicinal products and combination products up to marketing authorisation and beyond with the following services.

  • Regulatory strategy of product development
  • Support in preparing IMPD, IB, marketing authorisation dossiers

 

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

learn more

QP Services

QP services

Our experts are available for all quality-related questions. We support, advise and take responsibility.

  • Batch release of investigational medicinal products for human and veterinary use by our Qualified Person (QP)
  • Function as an external Qualified Person in your company
  • Qualification of suppliers, contract manufacturers and laboratories
  • Implementation, preparation and follow-​up of GMP/GDP audits
  • Interface in the cooperation and communication with authorities

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

learn more

QP services

QP services

Our experts are available for all quality-related questions. We support, advise and take responsibility.

  • Batch release of human and veterinary medicinal products by our Qualified Person (QP)
  • EU batch release for import of medicinal products into the EU
  • Function as an external Qualified Person (QP)
  • Qualification of suppliers, contract manufacturers and laboratories
  • Implementation, preparation of GMP/GDP audits and self-​inspections

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

learn more

QP services

QP services

Our experts are available for all quality-related questions. We support, advise and take responsibility.

  • Batch release of investigational medicinal products for human and veterinary use by our Qulified Person (QP)
  • Function as an external Qualified Person in your company
  • Qualification of suppliers, contract manufacturers and laboratories
  • Implementation, preparation and follow-​up of GMP/GDP audits
  • Interface in the cooperation and communication with authorities

After marketing authorisation we support, advice and take over responsibility and provide following services:

  • Batch release of human and veterinary medicinal products by our Qualified Person (QP)
  • EU batch release for import of medicinal products into the EU
  • Function as an external Qualified Person (QP)
  • Qualification of suppliers, contract manufacturers and laboratories
  • Implementation, preparation of GMP/GDP audits and self-​inspections

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

 

learn more

API

The quality of an active pharmaceutical ingredient is characterised by a number of chemical and physical characteristics that have a decisive influence on the quality of the finished product, its bioavailability, its stability and its other effects. With the aim of achieving optimal drug quality, it is essential to know the chemical and physical characteristics of the active ingredient in the early phase of drug development and to optimise them if necessary.

With the experience of many years and our large pool of analytical technologies and methods, we characterise your active substance and define these active substance properties required for optimal drug quality.

 

CMC development

We support you in the development and optimisation of solid, semi-solid and liquid dosage forms. Our spectrum ranges from tablets, hard capsules, film-coated tablets and granules to solutions and gels to technologically highly sophisticated formulations with poorly soluble active ingredients such as micro- and nanosuspensions. In addition to galenic development, our strengths are in analytical method development and regulatory support. In particular, we emphasise the wide range of chemical and physical analytical techniques that make the development process faster and more efficient. Process development and optimisation are among our core competencies. We always have in mind the scalability to later large-scale production.
In addition to our expertise in CMC development, you benefit from our extensive knowledge and experience in quality, preclinical and regulatory as well as our network for clinical development

Non-clinic

For the conduct of non-clinical in vivo and in vitro studies, we produce your formulation on a small scale under GMP conditions. With our partner institute, the Institute of Biochemistry and Molecular Biology at the University of Bonn, headed by Prof. Dr. Häberlein, we provide advice and support in the preclinical strategy and the conduct of preclinical studies on efficacy and tolerability as well as the elucidation of mechanisms of action (mode of action) in cell cultures or in animals.

Phase 1

We support you in preparation and implementation of your clinical trials and provide you with your clinical trial medication in accordance with applicable pharmaceutical standards and the highest quality standards.
From clinical conception to manufacturing, analytical release testing and QP batch release to distribution to the study centre, HWI is your reliable partner.

If you have a need to develop or optimise your product before the start of the clinical trial, please have a look at our CMC develoment to find out how HWI can support you.

 

Phase 2

We support you in preparation and implementation of your clinical trials and provide you with your clinical trial medication in accordance with applicable pharmaceutical standards and the highest quality standards.
From clinical conception to manufacturing, analytical release testing and QP batch release to distribution to the study centre, HWI is your reliable partner.

If you have a need to develop or optimise your product before the start of the clinical trial, please have a look at our CMC develoment to find out how HWI can support you.

Phase 3

We support you in preparation and implementation of your clinical trials and provide you with your clinical trial medication in accordance with applicable pharmaceutical standards and the highest quality standards.
From clinical conception to manufacturing, analytical release testing and QP batch release to distribution to the study centre, HWI is your reliable partner.

If you have a need to develop or optimise your product before the start of the clinical trial, please have a look at our CMC develoment to find out how HWI can support you.

 

Marketing authorisation

We support the marketing authorisation process with our broad expertise and many years of experience in drug development and manufacturing.

Product life-cycle management

Market changes and constantly changing regulatory requirements place manufacturers under permanent pressure to adapt or optimise medicinal products that are already being marketed.

The change management required for any changes to the product is also subject to strict regulatory requirements.

For your successful change management we offer:

  • Process and product optimisation
  • Upscaling
  • Production validation
  • GAP analysis
  • Product transfer (site transfer or tech transfer)
  • Method transfer
  • Regulatory compliance review
  • Efficient implementation of new regulatory requirements

Services Quicklinks

Company

The HWI group is an innovative service provider for Pharma & Biotech

The HWI group offers a broad range of individual and specialised pharmaceutical services for the pharma and biotech sector, particularly for active ingredients and medicinal products. Benefit from our long-standing experience in laboratory services, pharmacovigilance, QP services and drug development.

Learn more about HWI group

News

Media centre

Laboratory services, quality controll and QP services
Drug Development
Tableting under containment
Manufacturing and lyophilisation of a nanosuspension

Careers

More than work

Working in the HWI group means joining a fantastic team, developing it, shaping it – and having fun!

More on working in the HWI group

Hotline

Monday - Friday

+49 7272 7767-0