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HWI pharma services GmbH Products and Services                                                                       Rubric : service provider

Laboratory and Consultancy Services for Pharmaceutical Analytics and Quality Control
laboratory services - reference standards - vigilance & quality services
- analytical services for drug substances, drug products and borderline medicinal products -
- development and validation of analytical methods, batch release testing, stability testing and structure elucidation -


Content
Rubric / Technologies
Laboratory and Consultancy Services click here for the online shop reference standards
Company Profile



Rubric / Technologies

 

Rubric

  • service provider

Technologies

  • analytical methods - development and validation
  • certificates/certification
  • consulting
  • drug substances - drug safety
  • engineering
  • expert's report
  • identity testing
  • laboratory services
  • life cycle management
  • marketing authorisation services, ~ for Viglilance & Quality Services
  • pharmacovigilance
  • purity testing
  • quality control
  • quality management
  • refernce standards
  • standards - working~, R&D~, assay~, primary~, reference~
  • training
  • validation
  • vigilance systems for medicinal products

 

Laboratory and Consultancy Services

Laboratory Services Reference Standards Viglilance & Quality Services

 

Laboratory Services    -    HWI pharma services



HWI pharma services GmbH
Rheinzaberern Str. 8
76761 Rülzheim
Germany

 Telefon
+49 7272 7767-0
Telefax
+49 7272 7767-11

e-mail
info@hwi-group.de
homepage
http://www.hwi-group.de/en/landingpage/

 

 


laboratory services analysis API /
drug products
medicinal products consultation CMC

analytical services for
drug substances,
drug products,
borderline medicinal products

development and validation of
analytical methods,
batch release testing,
stability testing,
structure elucidation,
solution-oriented consultation of our clients

• analytical methods and finished drug products
• the complete range of pharmaceutical dosage forms
• pharmacopoeial testing (EP, USP, JP and others)
• Extractables & Leachables
• analysis of potentially genotoxic impurities

 

analytical testing and quality control of borderline medicinal devices as well as medicinal devices with ancillary drug substances

services for a consultation procedure according to MEDDEV- and MDD-guidelines and for Scientific Advice-meetings

development and validation of analytical methods for
identity testing,
assay,
purity testing,
dissolution testing of pharmaceutical drug substances

consultation in all analytical questions and relating regulatory questions the like as

setting and reviewing of specifications, analytical procedures and validations reports
• planning and conducting method transfers
• gap analyses of CTD modules 2.3/3

Reference Standards    -    HWI pharma services
HWI-standards primary standards working standards online-shop RS
für R&D
for identity and purity testing
for assay
a.o.

proof of identity using interpreted spectra
referencing of spectroscopic data with scientific literature
assay using two independent, validated methods
residual solvents
water content according to Karl-Fischer
a.o.

delivered with proof of identity and determined content
working standards for the testing of drug substances, intermediates and drug products without restrictions

online-shop reference standards
Viglilance & Quality Services    -  HWI pharma services
pharmacovigilance vigilance for medicinal devices quality management

life cycle management for medicinal products

The European pharmacovigilance system intends to provide patients and consumers with the best possible safety in using medicinal products.
Based on the recommendations provided in the guideline on Good Pharmacovigilance Practices (GVP), we offer to support you in all pharmacovigilance issues (e.g. QPPV, PSUR, RMP, PSMF).

search concerning risks that have become known in association with medical devices
collection and evaluation of the information obtained
clinical trial and clinical performance evaluation
market surveillance
benefit-risk assessment

establishment of your quality management system (including pharmacovigilance)
planning and performance of audits and self-inspections
interface for the cooperation and communication with authorities
a.o.

batch release by a Qualified Person from HWI
adoption of responsibility as external Qualified Person
maintenance and updating of marketing authorisations of medicinal products
preparation and submission of variations


Company Profile

 

Company Profile

HWI ANALYTIK GmbH was founded in 1991. We are relied upon by companies that appreciate contact on equal terms. With our long-standing experience and our striving for improvement, we provide laboratory and consultancy services in the divisions

• Laboratory Services
• Reference Standards
• Vigilance and Quality Services
• Drug Development

at a high quality standard.

HWI is working according to the requirements set by GMP as well as in compliance with GVP in pharmacovigilance. Furthermore we have a manufacturing authorisation for release testing of batches for clinical studies according to section 13 (1) of the German Drug Law (AMG).

 

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