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SYNLAB pharma institute: Laboratory expert for analytical services, laboratory logistics and clinical trials

The SYNLAB pharma institute offers a unique range of laboratory services to the biotechnology, pharmaceutical and cosmetic industries as well as to developers of medical devices, novel foods and crop protecting agents.

Our clients take advantage of our broad spectrum of analytical methods for clinical and preclinical studies as well as of our global logistical capabilities; always working in accordance with the highest available standards, GMP, GLP, GCLP or GCP

Please note our extensive experience gained from supporting more than 2,500 clinical trials and projects.

Over twenty years of analytical expertise!

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SYNLAB pharma institute emphasises the importance of an efficient sample management

Many sponsors decide to subcontract one central laboratory instead of many local labs when performing multi-center clinical studies. Here, a very important task when providing those central laboratory services is an efficient and safe sample management.

This article is taken from European Pharmaceutical Contractor February 2018, pages 46-48. © Samedan Ltd.

For more information please klick here.

Feb 16, 2018 | Pharma InstituteContinue
Our Service at the pharma institute of Structure Elucidation at a Glance
  • Analysis of genotoxic and highly potent substances, narcotic agents and chemotherapeutic agents
  • Analysis of substances with unknown biological and toxicological effects
  • Analysis of contaminants in DS/DP and stability studies
  • Preparative isolation of contaminants

At SYNLAB, we distinguish between the following 3 types of analyses:

1. Structure elucidation of unknown by- and degradation products
According to our clients we are the best for structure elucidation. Whether you’re dealing with degradation products, genotoxic impurities, or leachables and extractables: we are very skilled at finding the right structures.

2. Unknown impurities
Contaminants occur not only during early development of medicinal products but also, for example, during stability tests or when changes are made to formulations. There are many different reasons for this: e.g. other synthesis paths, interactions with excipients and packaging materials, polymorphic transitions, etc. If the concentration of a by-product and/or degradation product exceeds a specified limit value, the structure of this impurity must be determined. Structure elucidation is frequently followed by the targeted synthesis of the impurity and its analytical qualification as a reference standard.

3. Genotoxic impurities/leachables & extractables 
The regulatory agencies (FDA, EMA) focus especially on genotoxic impurities, and leachables and extractables. Low detection limits in the trace range (ppm, ppb) call for special analytical techniques (LC-Q-ToF-MS) to detect these substances.

 

Jan 26, 2018 | Pharma InstituteContinue
Support of Diagnostics Industry by the SYNLAB pharma institute

SYNLAB pharma institute has many years of experience  and various capabilities to support both kits - and diagnostic instruments manufacturers in the field of release / approval studies.

We cover all diagnostic areas, with a special focus on flow cytometry and genetic markers. Together with our partners, we are able to achieve both, CE- and/or IVD-labels for your product!

Did we spark your interest or do you have any further questions?

Please contact us at: pharma@synlab.com

 

Dec 18, 2017 | Pharma InstituteContinue
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