Pharmacovigilance / Drug Safety
Product Description
HWI pharma services GmbH
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Country/Region:Germany
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Founded:1991
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On CPHI since:2015
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Certificates:2
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Employees:100 - 249
Company types
Primary activities
Categories
HWI pharma services GmbH
-
Country/Region:Germany
-
Founded:1991
-
On CPHI since:2015
-
Certificates:2
-
Employees:100 - 249
Company types
Primary activities
More Products from HWI pharma services GmbH (9)
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Product Laboratory Services
We offer the development and validation of test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices. Our method development and method validation are in accordance wit... -
Product Drug Development / Formulation Development
Our services include: • Development of new drug products, innovative products for poorly soluble active ingredients or new applications • Optimisation and reformulation of existing products • Generic developments • Development of herbal medicinal products • Manufacturing, primary and secondary packagin... -
Product Clinical Trial Manufacturing, Packaging, Labelling, Serialisation
Our services for clinical trial batches:
• Manufacturing an tailor-made primary, secondary and tertiary packagingLabelling of primary, secondary and tertiary packaging • Customised labelling incl. blinding/randomisation • IMPD WritingDevelopment and packaging of individual patient kits • Release and... -
Product QP Services
As part of our QP services and our pharmaceutical consulting, we offer you comprehensive monitoring and assurance of product quality in accordance with the Good Manufacturing Practice (GMP) guidelines and the specific requirements of § 13 AMG. We provide the following services:
• Setting up your Q... -
Product Batch release
We take responsibility for releasing your drug batches in accordance with the requirements of the EU GMP guidelines and the German Medicinal Products Act (AMG).
Our services at a glance: • Batch release in accordance with EU GMP Annex 16 by our QPs • Batch certification for human and veterinary... -
Product Filling of powders for terminal sterilisation
Filling of powders for terminal sterilisation. We offer powder formulation services, feasibility studies, and the transfer from laboratory to production scale, as well as sterile filling of active pharmaceutical ingredients (APIs) and powder-based finished products.
All filling o... -
Product GVP-Audits services
As an interdisciplinary team with many years of experience in drug safety, we advise you on all aspects of pharmacovigilance and support you in conducting GVP audits – fully aligned with current GVP guidelines. This includes, among other things, the planning, conduct, and follow-up of your GVP audits.
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Product Manufacturing of small to medium sized batches
We are specialised in the Manufacturing of small market batches under GMP conditions. In addition to our many years of experience, we also have a wide range of technological and analytical equipment for the development, manufacture and characterisation of medicinal products. Besides conventional manuf... -
Product Technologie platform for small and large molecules
HWI technology platform provides innovative formulations for small and large molecules. It offers interesting solutions for fast and cost-efficient development, for example, for parenteral and nasal application of poorly soluble active ingredients
HWI pharma services GmbH resources (8)
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Video Tableting with high potent active ingredients at Frankfurt Site
We show you the manufacturing of tablets with high potent active ingredients. In our clean rooms, solid oral dosage forms are being developed and small scale as well as clinical trial batches produced under GMP conditions. How we do it – have a look! -
Video Manufacturing and lyophilisation of a nanosuspension
Innovative technologies for the development and production of semi-solid and liquid dosage forms are part of our wide range of services in drug development. We will show you the manufacturing of a nanosuspension with subsequent lyophilization under GMP conditions. -
Datasheet HWI group One Pager - Services for Phama & 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, vigilance and quality services, drug development as well as regulatory affairs services.
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Brochure HWI group presentation
Company presentation of HWI group. HWI is a family-owned, independent service partner in the pharma and biotech sector. It stands for quality, flexibility, competence and reliability.
With more than 35 years of experience HWI offers a service portfolio ranging from formulation development, analytical development and quality control, manufacturing of clinical batches and smaller market batches to pre-clinical development, pharmacovigilance and GxP services.
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Brochure Laboratory Services HWI group
With more than 35 years of experience and our continual quest for improvement, we provide analytical laboratory services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch release analysis, stability testing and structure determination of unknown substances, our core expertise also includes risk-based and solutions-oriented client consulting. -
Brochure Drug Development Services
HWI has been a leading company in drug development for many years. Our experts take innovative therapeutic approaches from conception to market launch. As a CDMO, we also develop and manufacture for our customers on a contract basis. Our services include formulation development and manufacture as well as analytical method development and characterisation for for solid, semi-solid and liquid medicinal products. -
Brochure Drug Saftey Services / Pharmacovigilance
We are an experienced and interdisciplinary team. Based on good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters. We support you in conducting GVP audits – fully aligned with current GVP guidelines. This includes, among other things, the planning, conduct, and follow-up of your GVP audits. -
Datasheet End-to-End service concept
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.
Our services cover the entire value chain ofmedicinal products with small and large molecules.