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News Headlines

GCP Inspection

A new certificate of GCP compliance was issued on 08th January 2015

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GLP Inspection

CEMAS has been inspected by the United Kingdom GLP Monitoring Authority

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REACH

REACh (Registration, Evaluation, Authorisation and Restriction of Chemicals)

CEMAS services to support registration of substances within the EU

The REACh Proposal

Under the new EU system of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACh), enterprises that manufacture or import more than one tonne of a chemical substance per year are required to register it with the new European Chemicals Agency.  Each registration submission consists of a Technical Dossier and, for substances above 10 tonnes, a Chemical Safety Report (CSR). Failure to register will mean that the substance cannot be manufactured or imported. The REACh legislation means that approximately 30,000 existing substances will need to be registered by 2018.

CEMAS can help meet the regulatory requirements of the REACh programme, offering a wide range of tests, conducted to EU standardised testing methods in accordance with Good Laboratory Practice (GLP), and providing information to aid preparation and submission of the required technical dossier.

CEMAS analytical services

CEMAS can carry out all necessary analytical studies to meet the requirements of REACh including:

  • Physical-Chemical Testing. All required tests for all the tonnage categories.
  • Methods of Detection and Analysis, including Method Development and Validation
  • Storage Stability Studies 

CEMAS sees continual investment in state-of-the-art instrumentation as crucial to our success. Spark-HollandTM Pharma technology has been acquired to complement our LC/MS/MS (Sciex API 4000 and 5000) systems.  CEMAS has both ambient and environmentally controlled storage for accelerated and long-term storage stability studies. 

Study design, protocol and reporting are tailored to satisfy regulatory requirements using both CEMAS standard procedures and specific customer requirements. 

News Headlines

GCP Inspection

A new certificate of GCP compliance was issued on 08th January 2015

read on

GLP Inspection

CEMAS has been inspected by the United Kingdom GLP Monitoring Authority

read on

Contact Us for more Information

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Contact

Tel:+ 44 (0)1344 887 100