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HWI group - innovative technologies and services for API and
medicinal products |
rubric : service provider |
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HWI group provides at 3 sites in Germany a wide range of inividual and specialised pharmceutical services for pharma & biotech,
especially for active ingrdients and medicinal products.
Benefit from our long-standing experience in laboratory services, pharmacovigilance and QP services, API assessment as well as drug development.
In regulat0ry affairs services we work together with an external partner. |
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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
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- Life Cycle Management
- API characterization
- Drug Development / innovative formulation (parenteral, nasal, solid, semi-solid)
- small batches und clinical trial batches
(incl. serialisation, labeling, packaging)
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Laboratory Services - Pharmacovigilance & QP services - Drug Development Services / innovative formulation
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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 |
assay standards |
Ident- and purity 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
• 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 physica 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 |
• isolatopn and qualification of pharmaceutical reference standards in accordance with all legal and regularity
requirements
in the GMP environment
• qualification of pharmaceutical reference standards including dossier preparation for submission in 3.2.P.5.6
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• rimary reference standards (complete documentation)
• working standards
(batch-related CoA) |
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Pharmacovigilance & QP 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 self-inspections
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• batch release by a Qualified Person from HWI or as external Qualified Person |
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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, powder
• 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
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Group Profile |
HWI pharma services, headquarters Ruelzheim
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 copmpliance
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.
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.
Appenweier site
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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